Details for New Drug Application (NDA): 204778
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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. Seventeen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
Summary for 204778
Tradename: | DORZOLAMIDE HYDROCHLORIDE |
Applicant: | Micro Labs |
Ingredient: | dorzolamide hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204778
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 204778
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DORZOLAMIDE HYDROCHLORIDE | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204778 | ANDA | Micro Labs Limited | 42571-141 | 42571-141-26 | 1 BOTTLE in 1 CARTON (42571-141-26) / 10 mL in 1 BOTTLE |
DORZOLAMIDE HYDROCHLORIDE | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204778 | ANDA | A-S Medication Solutions | 50090-4882 | 50090-4882-0 | 1 BOTTLE in 1 CARTON (50090-4882-0) / 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: | Nov 8, 2019 | TE: | AT | RLD: | No |
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