Details for New Drug Application (NDA): 202053
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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 202053
Tradename: | DORZOLAMIDE HYDROCHLORIDE |
Applicant: | Indoco |
Ingredient: | dorzolamide hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 202053
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 202053
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DORZOLAMIDE HYDROCHLORIDE | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 202053 | ANDA | Indoco Remedies Limited | 14445-404 | 14445-404-10 | 1 BOTTLE, DISPENSING in 1 CARTON (14445-404-10) / 10 mL in 1 BOTTLE, DISPENSING |
DORZOLAMIDE HYDROCHLORIDE | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 202053 | ANDA | Biocon Pharma Inc. | 70377-081 | 70377-081-11 | 1 BOTTLE, DISPENSING in 1 CARTON (70377-081-11) / 10 mL in 1 BOTTLE, DISPENSING |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 2% BASE | ||||
Approval Date: | Sep 11, 2014 | TE: | AT | RLD: | No |
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