Details for New Drug Application (NDA): 212639
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The generic ingredient in DORZOLAMIDE HYDROCHLORIDE is dorzolamide hydrochloride; timolol maleate. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
Summary for 212639
Tradename: | DORZOLAMIDE HYDROCHLORIDE |
Applicant: | Alembic |
Ingredient: | dorzolamide hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 212639
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 212639
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DORZOLAMIDE HYDROCHLORIDE | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 212639 | ANDA | Alembic Pharmaceuticals Limited | 46708-519 | 46708-519-10 | 1 BOTTLE in 1 CARTON (46708-519-10) / 10 mL in 1 BOTTLE |
DORZOLAMIDE HYDROCHLORIDE | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 212639 | ANDA | Alembic Pharmaceuticals Inc. | 62332-519 | 62332-519-10 | 1 BOTTLE in 1 CARTON (62332-519-10) / 10 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 2% BASE | ||||
Approval Date: | Aug 9, 2019 | TE: | AT | RLD: | No |
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