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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091180

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NDA 091180 describes DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, which is a drug marketed by Apotex Inc, Sandoz Inc, 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 nine 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. Ten suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Summary for NDA: 091180

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 091180

Suppliers and Packaging for NDA: 091180

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 091180 ANDA ALVOGEN INC. 47781-136 47781-136-34 1 VIAL in 1 CARTON (47781-136-34) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE;EQ 0.5% BASE
Approval Date:Dec 4, 2013TE:ATRLD:No


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Federal Trade Commission
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Fish and Richardson

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