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Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091572

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NDA 091572 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Akorn, 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 fourteen NDAs. It is available from twelve 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 091572
Applicant:Apotex Inc
Ingredient:olopatadine hydrochloride
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091572
Suppliers and Packaging for NDA: 091572
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SPRAY, METERED;NASAL 091572 ANDA Apotex Corp. 60505-0845 N 60505-0845-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.665MG/SPRAY
Approval Date:Oct 8, 2014TE:ABRLD:No

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