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Serving leading biopharmaceutical companies globally:

Julphar
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Dow
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Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078981

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NDA 078981 describes DORZOLAMIDE HYDROCHLORIDE, which is a drug marketed by Zambon Spa, Bausch And Lomb, Hi Tech Pharma, Sandoz Inc, Watson Labs Inc, Teva Pharms, Luitpold, Apotex Inc, Sandoz, 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. Eleven suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Summary for NDA: 078981

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
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
dorzolamide hydrochloride
SOLUTION/DROPS;OPHTHALMIC 078981 ANDA Sandoz Inc. 61314-019 61314-019-05 5 mL in 1 BOTTLE (61314-019-05)
DORZOLAMIDE HYDROCHLORIDE
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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Serving leading biopharmaceutical companies globally:

Argus Health
McKinsey
Federal Trade Commission
Moodys
Cerilliant
Healthtrust
Cipla
Merck
Farmers Insurance
Boehringer Ingelheim

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