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Details for New Drug Application (NDA): 203058

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NDA 203058 describes DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, which is a drug marketed by Apotex Inc, Alcon Res, Teva Pharms, Bausch And Lomb, Hi Tech Pharma, Sandoz, Watson Labs Inc, Akorn Inc, Zach Systems, and Lannett Holdings Inc, and is included in ten NDAs. It is available from eleven 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 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: 203058

Pharmacology for NDA: 203058

Suppliers and Packaging for NDA: 203058

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dorzolamide hydrochloride; timolol maleate
SOLUTION/DROPS;OPHTHALMIC 203058 ANDA Akorn, Inc. 17478-514 17478-514-11 1 BOTTLE, DROPPER in 1 CARTON (17478-514-11) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE;EQ 0.5% BASE
Approval Date:Sep 22, 2014TE:ATRLD:No

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