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Generated: October 23, 2018

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Details for New Drug Application (NDA): 090848

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NDA 090848 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Akorn, Akorn Inc, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Cipla Ltd, Mylan Pharms Inc, Somerset Theraps Llc, Usv North America, Wockhardt Ltd, Zambon Spa, and Perrigo Israel, and is included in fifteen NDAs. It is available from fourteen suppliers. Additional details are available on the OLOPATADINE HYDROCHLORIDE profile page.

The generic ingredient in OLOPATADINE HYDROCHLORIDE is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 090848
Tradename:OLOPATADINE HYDROCHLORIDE
Applicant:Barr Labs Inc
Ingredient:olopatadine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090848
Suppliers and Packaging for NDA: 090848
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 090848 ANDA Teva Pharmaceuticals USA, Inc. 0093-7684 0093-7684-32 1 BOTTLE, DROPPER in 1 CARTON (0093-7684-32) > 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.2% BASE
Approval Date:Jul 13, 2015TE:ATRLD:No

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