Details for New Drug Application (NDA): 090037
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NDA 090037 describes DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, which is a drug marketed by Alembic, Bausch And Lomb, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Ingenus Pharms Llc, Micro Labs, Rubicon, Sandoz, Somerset, Teva Pharms, and Zambon Spa, and is included in nineteen NDAs. It is available from sixteen suppliers. Additional details are available on the DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE profile page.
The generic ingredient in DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE 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 AND TIMOLOL MALEATE 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 090037
| Tradename: | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE |
| Applicant: | Bausch And Lomb |
| Ingredient: | dorzolamide hydrochloride; timolol maleate |
| Patents: | 0 |
Pharmacology for NDA: 090037
| Mechanism of Action | Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 090037
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 090037 | ANDA | Bausch & Lomb Incorporated | 24208-486 | 24208-486-05 | 1 BOTTLE, DROPPER in 1 CARTON (24208-486-05) / 5 mL in 1 BOTTLE, DROPPER |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 090037 | ANDA | Bausch & Lomb Incorporated | 24208-486 | 24208-486-10 | 1 BOTTLE, DROPPER in 1 CARTON (24208-486-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 2% BASE;EQ 0.5% BASE | ||||
| Approval Date: | Jul 14, 2009 | TE: | AT1 | RLD: | No | ||||
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