Details for New Drug Application (NDA): 205294
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NDA 205294 describes DORZOLAMIDE HYDROCHLORIDE, which is a drug marketed by Alembic, Am Regent, Bausch And Lomb, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Micro Labs, Rubicon, Sandoz, Teva Pharms, Zambon Spa, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Ingenus Pharms Llc, and Somerset, and is included in thirty-two NDAs. It is available from twelve suppliers. Additional details are available on the DORZOLAMIDE HYDROCHLORIDE profile page.
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.
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 205294
| Tradename: | DORZOLAMIDE HYDROCHLORIDE |
| Applicant: | Fdc Ltd |
| Ingredient: | dorzolamide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205294
| Mechanism of Action | Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 205294
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DORZOLAMIDE HYDROCHLORIDE | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 205294 | ANDA | Leading Pharma, LLC | 69315-304 | 69315-304-05 | 1 BOTTLE in 1 CARTON (69315-304-05) / 5 mL in 1 BOTTLE |
| DORZOLAMIDE HYDROCHLORIDE | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 205294 | ANDA | Leading Pharma, LLC | 69315-304 | 69315-304-10 | 1 BOTTLE in 1 CARTON (69315-304-10) / 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: | Jan 24, 2019 | TE: | AT | RLD: | No | ||||
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