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Details for New Drug Application (NDA): 078981

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NDA 078981 describes DORZOLAMIDE HYDROCHLORIDE, which is a drug marketed by Zach Systems, Bausch And Lomb, Hi Tech Pharma, Sandoz, Watson Labs Inc, Teva Pharms, Sandoz Inc, Luitpold, Apotex Inc, Alcon Res, Akorn Inc, and Lannett Holdings Inc, and is included in nineteen NDAs. It is available from nine 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. Twelve suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Summary for NDA: 078981

Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 078981

Mechanism of ActionCarbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 078981

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dorzolamide hydrochloride
SOLUTION/DROPS;OPHTHALMIC 078981 ANDA Sandoz Inc. 61314-019 61314-019-05 5 mL in 1 BOTTLE (61314-019-05)
dorzolamide hydrochloride
SOLUTION/DROPS;OPHTHALMIC 078981 ANDA Sandoz Inc. 61314-019 61314-019-10 10 mL in 1 BOTTLE (61314-019-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE
Approval Date:Apr 13, 2009TE:ATRLD:No

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