Details for New Drug Application (NDA): 078981
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NDA 078981 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. Eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
Summary for 078981
| Tradename: | DORZOLAMIDE HYDROCHLORIDE |
| Applicant: | Sandoz |
| Ingredient: | dorzolamide hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078981
| Mechanism of Action | Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 078981
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DORZOLAMIDE HYDROCHLORIDE | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 078981 | ANDA | Sandoz Inc | 61314-019 | 61314-019-10 | 10 mL in 1 BOTTLE (61314-019-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 2% BASE | ||||
| Approval Date: | Apr 13, 2009 | TE: | AT | RLD: | No | ||||
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