Details for New Drug Application (NDA): 204777
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NDA 204777 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 204777
| Tradename: | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE |
| Applicant: | Micro Labs |
| Ingredient: | dorzolamide hydrochloride; timolol maleate |
| Patents: | 0 |
Pharmacology for NDA: 204777
| Mechanism of Action | Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 204777
| 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 | 204777 | ANDA | Micro Labs Limited | 42571-147 | 42571-147-26 | 1 BOTTLE in 1 CARTON (42571-147-26) / 10 mL in 1 BOTTLE |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 204777 | ANDA | A-S Medication Solutions | 50090-6814 | 50090-6814-0 | 1 BOTTLE in 1 CARTON (50090-6814-0) / 10 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 2% BASE;EQ 0.5% BASE | ||||
| Approval Date: | May 28, 2020 | TE: | AT1 | RLD: | No | ||||
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