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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090919

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NDA 090919 describes EPINASTINE HYDROCHLORIDE, which is a drug marketed by Apotex, Sun Pharm Inds, Somerset Theraps Llc, Akorn, Breckenridge Pharm, and Sandoz Inc, 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 NDA: 090919

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 090919

Suppliers and Packaging for NDA: 090919

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPINASTINE HYDROCHLORIDE
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 090919 ANDA Apotex Corp. 60505-0584 60505-0584-1 1 BOTTLE, PLASTIC in 1 CARTON (60505-0584-1) > 5 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

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


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