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Timolol Maleate Patent Expiration

Timolol Maleate was first introduced by Merck Research Laboratories Div Merck Co Inc in its drug Blocadren on Approved Prior to Jan 1, 1982. Other drugs containing Timolol Maleate are Timoptic-Xe, Timoptic, Timoptic In Ocudose, Timolol Maleate, Istalol. 33 different companies have introduced drugs containing Timolol Maleate.


Timolol Maleate Patents

Given below is the list of patents protecting Timolol Maleate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Timolol Maleate US6174524

(Pediatric)

 Gelling ophthalmic compositions containing xanthan gum Sep 26, 2019

(Expired)

 Sandoz
Timolol Maleate US6174524 Gelling ophthalmic compositions containing xanthan gum Mar 26, 2019

(Expired)

 Sandoz
Istalol US6645963 Prolonged-action eye drop Nov 16, 2018

(Expired)

 Bausch And Lomb
Istalol US6335335 Prolonged-action eye drop Nov 02, 2018

(Expired)

 Bausch And Lomb



Timolol Maleate's Family Patents

Family Patents

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Timolol Maleate Generic API Manufacturers

Several generic applications have been filed for Timolol Maleate. The first generic version for Timolol Maleate was by Usl Pharma Inc and was approved on Apr 11, 1989. And the latest generic version is by Somerset Therapeutics Llc and was approved on Sep 16, 2024.

Given below is the list of companies who have filed for Timolol Maleate generic, along with the locations of their manufacturing plants worldwide.


1. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.25% BASE

(reference standard)

solution, gel forming/drops Prescription OPHTHALMIC AB Oct 22, 2020
EQ 0.5% BASE

(reference standard)

solution, gel forming/drops Prescription OPHTHALMIC AB Oct 22, 2020


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Panelav Alembic Pharmaceuticals Limited
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal Alembic Pharmaceuticals Limited





2. AMNEAL

Amneal Eu Ltd has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.25% BASE

solution, gel forming/drops Discontinued OPHTHALMIC N/A May 23, 2024
EQ 0.5% BASE

solution, gel forming/drops Discontinued OPHTHALMIC N/A May 23, 2024


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Paterson Amneal Pharmaceuticals, Llc
Hauppauge Amneal Pharmaceuticals of New York, LLC
East Hanover Amneal Pharmaceuticals LLC
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited





3. AMRING PHARMS

Amring Pharmaceuticals Inc has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Amring Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.25% BASE

solution/drops Prescription OPHTHALMIC AT3 Dec 13, 2021
EQ 0.5% BASE

solution/drops Prescription OPHTHALMIC AT3 Dec 13, 2021





4. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 3 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Ani Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Jul 31, 1991
5MG

tablet Discontinued ORAL N/A Jul 31, 1991
20MG

tablet Discontinued ORAL N/A Jul 31, 1991





5. APOTEX

Apotex Inc has filed for 1 generic for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution/drops Prescription OPHTHALMIC AT2 Apr 17, 2015


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
North York Apotex Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
Brantford Apotex Pharmachem Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bangalore Apotex Pharmachem India Pvt Ltd.
Bengaluru Apotex Research Private Limited





6. APOTEX INC

Apotex Inc has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Apotex Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.25% BASE

solution/drops Discontinued OPHTHALMIC N/A Sep 8, 2000
EQ 0.5% BASE

solution/drops Discontinued OPHTHALMIC N/A Sep 8, 2000


Manufacturing Plant Locations
New

Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.

Country City Firm Name
Canada
Toronto Apotex Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.





7. BAUSCH AND LOMB

Bausch And Lomb Pharmaceuticals Inc has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Bausch And Lomb.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution/drops Discontinued OPHTHALMIC N/A Mar 25, 1997
EQ 0.25% BASE

solution/drops Discontinued OPHTHALMIC N/A Mar 25, 1997


Manufacturing Plant Locations
New

Bausch And Lomb's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bausch And Lomb as present at those locations.

Country City Firm Name
United States
Irvine Bausch and Lomb, Incorporated
Bridgewater Bausch and Lomb, Inc
Rancho Cucamonga Bausch and Lomb, Incorporated





8. CAPLIN

Caplin Steriles Ltd has filed for 1 generic for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Caplin.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution/drops Prescription OPHTHALMIC AT1 Aug 7, 2024


Manufacturing Plant Locations
New

Caplin's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Caplin as present at those locations.

Country City Firm Name
United States
Creve Coeur Caplin, Dr David
India
Gummidipoondi Caplin Steriles Limited





9. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 3 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Discontinued ORAL N/A Apr 13, 1989
20MG

tablet Discontinued ORAL N/A Apr 13, 1989
10MG

tablet Discontinued ORAL N/A Apr 13, 1989





10. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.25% BASE

solution, gel forming/drops Prescription OPHTHALMIC AB Sep 22, 2022
EQ 0.5% BASE

solution, gel forming/drops Prescription OPHTHALMIC AB Sep 22, 2022





11. EPIC PHARMA LLC

Epic Pharma Llc has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.25% BASE

solution/drops Discontinued OPHTHALMIC N/A Mar 25, 1997
EQ 0.5% BASE

solution/drops Prescription OPHTHALMIC AT3 Sep 11, 2020





12. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution, gel forming/drops Prescription OPHTHALMIC AB Mar 23, 2023


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited





13. FDC LTD

Fdc Ltd has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Fdc Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution/drops Prescription OPHTHALMIC AT1 Apr 30, 2008
EQ 0.25% BASE

solution/drops Prescription OPHTHALMIC AT1 Apr 30, 2008





14. FOUGERA

E Fougera Div Altana Inc has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Fougera.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution/drops Discontinued OPHTHALMIC N/A Mar 25, 1997
EQ 0.25% BASE

solution/drops Discontinued OPHTHALMIC N/A Mar 25, 1997


Manufacturing Plant Locations
New

Fougera's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fougera as present at those locations.

Country City Firm Name
United States
Hicksville Fougera Pharmaceuticals, Inc.
Melville Fougera Pharmaceuticals Inc.
Mechanicsburg Fougera Pharmaceuticals Inc.





15. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.25% BASE

solution, gel forming/drops Prescription OPHTHALMIC AB Jun 24, 2022
EQ 0.5% BASE

solution, gel forming/drops Prescription OPHTHALMIC AB Feb 14, 2023





16. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution/drops Discontinued OPHTHALMIC N/A Sep 10, 2002


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





17. INGENUS PHARMS LLC

Ingenus Pharmaceuticals Llc has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Ingenus Pharms Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.25% BASE

solution/drops Prescription OPHTHALMIC AT3 Sep 13, 2022
EQ 0.5% BASE

solution/drops Prescription OPHTHALMIC AT3 Sep 13, 2022





18. MANKIND PHARMA

Mankind Pharma Ltd has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Mankind Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.25% BASE

solution/drops Prescription OPHTHALMIC AT1 Sep 28, 2009
EQ 0.5% BASE

solution/drops Prescription OPHTHALMIC AT1 Sep 28, 2009


Manufacturing Plant Locations
New

Mankind Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Mankind Pharma as present at those locations.

Country City Firm Name
India
Paonta Sahib Mankind Pharma Limited
Imt Manesar Mankind Pharma Limited





19. MICRO LABS

Micro Labs Ltd has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution/drops Prescription OPHTHALMIC AT1 May 26, 2023
EQ 0.25% BASE

solution/drops Prescription OPHTHALMIC AT1 May 26, 2023


Manufacturing Plant Locations
New

Micro Labs's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Micro Labs as present at those locations.

Country City Firm Name
India
Verna Micro Labs Limited
Bengaluru Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory
Bangalore Micro Labs Limited





20. MYLAN

Mylan Pharmaceuticals Inc has filed for 3 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Jun 8, 1990
10MG

tablet Prescription ORAL AB Jun 8, 1990
20MG

(reference standard)

tablet Prescription ORAL AB Jun 8, 1990


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Greensboro Mylan Pharmaceuticals Inc
Morgantown Mylan Specialty, L.P.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Saint Albans Mylan Technologies, Inc.
Rockford Mylan Institutional, Inc.
San Carlos Mylan Pharmaceuticals Inc.
India
Aurangabad Mylan Laboratories Limited (FDF-2)
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





21. PACIFIC PHARMA

Pacific Pharma has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Pacific Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.25% BASE

solution/drops Prescription OPHTHALMIC AT1 Mar 25, 1997
EQ 0.5% BASE

solution/drops Prescription OPHTHALMIC AT1 Mar 25, 1997





22. QUANTUM PHARMICS

Quantum Pharmics Ltd has filed for 3 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Quantum Pharmics.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Discontinued ORAL N/A May 19, 1989
10MG

tablet Discontinued ORAL N/A May 19, 1989
20MG

tablet Discontinued ORAL N/A May 19, 1989





23. RISING

Rising Pharma Holdings Inc has filed for 3 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB May 2, 2019
10MG

tablet Prescription ORAL AB May 2, 2019
20MG

tablet Prescription ORAL AB May 2, 2019


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
Rising Sun Rising Sun Veterinary Clinic
Fort Bragg Rising Tide Sea Vegetables
Mount Morris Rising Creek Bakery LLC
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Phoenix Rising Sun Farms Inc
East Brunswick Rising Pharma Holding, Inc.
Livingston Risingsun Iodine Products Corp.
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





24. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.25% BASE

(reference standard)

solution/drops Prescription OPHTHALMIC AT1 Apr 28, 1995
EQ 0.5% BASE

(reference standard)

solution/drops Prescription OPHTHALMIC AT1 Apr 28, 1995


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Langkampfen Sandoz GmbH
Kundl Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





25. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 1 generic for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution/drops Discontinued OPHTHALMIC N/A Mar 25, 1997





26. SENTISS PHARMA

Sentiss Pharma Private Ltd has filed for 1 generic for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Sentiss Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution/drops Prescription OPHTHALMIC AT3 May 8, 2023


Manufacturing Plant Locations
New

Sentiss Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Sentiss Pharma as present at those locations.

Country City Firm Name
India
District Solan Sentiss Pharma Pvt. Ltd.





27. SOMERSET

Somerset Therapeutics Llc has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Somerset.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution/drops Prescription OPHTHALMIC AT1 Jul 3, 2024
EQ 0.25% BASE

solution/drops Prescription OPHTHALMIC AT1 Jul 3, 2024


Manufacturing Plant Locations
New

Somerset's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Somerset as present at those locations.

Country City Firm Name
United States
Somerville Somerset Medical Center IRB
Fairfield Somerset Auction Company, LLC
India
Bengaluru Somerset Therapeutics Limited





28. SOMERSET THERAPS LLC

Somerset Therapeutics Llc has filed for 2 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Somerset Theraps Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5% BASE

solution, gel forming/drops Prescription OPHTHALMIC AB Sep 16, 2024
EQ 0.25% BASE

solution, gel forming/drops Prescription OPHTHALMIC AB Sep 16, 2024





29. TEVA

Teva Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Jun 16, 1993
20MG

tablet Discontinued ORAL N/A Jun 16, 1993
5MG

tablet Discontinued ORAL N/A Jun 16, 1993


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Fort Dodge TEVA Animal Health Inc
Horsham Teva Branded Pharmaceutical Products R&D
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Miami Teva Branded Pharmaceutical Products R & D, Inc.
India
Gajraula, Amroha Teva API India Private Ltd.
Bhind Teva API India Ltd- Malanpur
Canada
Stouffville Teva Canada Limited
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





30. USL PHARMA

Usl Pharma Inc has filed for 3 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Usl Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Discontinued ORAL N/A Apr 11, 1989
20MG

tablet Discontinued ORAL N/A Apr 11, 1989
10MG

tablet Discontinued ORAL N/A Apr 11, 1989





31. WATSON LABS

Watson Laboratories Inc has filed for 3 different strengths of generic version for Timolol Maleate. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Discontinued ORAL N/A Apr 11, 1989
10MG

tablet Discontinued ORAL N/A Apr 11, 1989
5MG

tablet Discontinued ORAL N/A Apr 11, 1989