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Serving leading biopharmaceutical companies globally:

McKesson
Cipla
Covington
Farmers Insurance
Cerilliant
Medtronic
Colorcon
Accenture
Novartis
Baxter

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203152

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NDA 203152 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Cipla Ltd, Somerset Theraps Llc, Usv North America, Wockhardt Ltd, Zambon Spa, and Perrigo Israel, and is included in eleven NDAs. It is available from thirteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 203152
Tradename:OLOPATADINE HYDROCHLORIDE
Applicant:Usv North America
Ingredient:olopatadine hydrochloride
Patents:0
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203152
Suppliers and Packaging for NDA: 203152
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 203152 ANDA Rising Pharmaceuticals, Inc. 64980-517 64980-517-05 1 BOTTLE, DROPPER in 1 CARTON (64980-517-05) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.1% BASE
Approval Date:Dec 7, 2015TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Mallinckrodt
Moodys
AstraZeneca
Accenture
Federal Trade Commission
Novartis
US Department of Justice

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