BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Boehringer Ingelheim
Farmers Insurance
Express Scripts

Generated: January 23, 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, Sandoz 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
Applicant:Sun Pharm Inds
Ingredient:epinastine hydrochloride
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 62756-329-90 1 BOTTLE in 1 CARTON (62756-329-90) > 5 mL in 1 BOTTLE

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 leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
US Department of Justice

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