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Details for New Drug Application (NDA): 078756

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NDA 078756 describes DORZOLAMIDE HYDROCHLORIDE, which is a drug marketed by Zach Systems, Bausch And Lomb, Hi Tech Pharma, Sandoz, Watson Labs Inc, Teva Pharms, Alcon Pharms Ltd, Luitpold, Apotex Inc, Alcon Res, Akorn Inc, and Lannett Holdings Inc, and is included in nineteen NDAs. It is available from ten suppliers. Additional details are available on the DORZOLAMIDE HYDROCHLORIDE profile page.

The generic ingredient in DORZOLAMIDE HYDROCHLORIDE is dorzolamide hydrochloride; timolol maleate. There are fourteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Summary for NDA: 078756

Teva Pharms
dorzolamide hydrochloride
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 078756

Mechanism of ActionCarbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 078756

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dorzolamide hydrochloride
SOLUTION/DROPS;OPHTHALMIC 078756 ANDA Teva Pharmaceuticals USA, Inc. 0093-7618 0093-7618-43 1 BOTTLE in 1 CARTON (0093-7618-43) > 10 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE
Approval Date:Dec 4, 2008TE:ATRLD:No

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