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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Citi
Healthtrust
US Army
Express Scripts
Moodys
McKesson
Accenture
Harvard Business School

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091626

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NDA 091626 describes EPINASTINE HYDROCHLORIDE, which is a drug marketed by Akorn, Apotex, Breckenridge Pharm, Casi Pharms Inc, Somerset Theraps Llc, and Sun Pharm Inds, and is included in six NDAs. It is available from five suppliers. Additional details are available on the EPINASTINE HYDROCHLORIDE profile page.

The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the epinastine hydrochloride profile page.
Summary for 091626
Tradename:EPINASTINE HYDROCHLORIDE
Applicant:Sun Pharm Inds
Ingredient:epinastine hydrochloride
Patents:0
Therapeutic Class:Ophthalmic Agents
Pharmacology for NDA: 091626
Suppliers and Packaging for NDA: 091626
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPINASTINE HYDROCHLORIDE epinastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 091626 ANDA Sun Pharmaceutical Industries Limited 62756-329 N 62756-329-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Oct 31, 2011TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Boehringer Ingelheim
US Army
Healthtrust
Medtronic
AstraZeneca
Cipla
Farmers Insurance
Baxter

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