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Last Updated: September 18, 2020

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Details for New Drug Application (NDA): 204812

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NDA 204812 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Akorn, Akorn Inc, Alembic Pharms Ltd, Apotex, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Cipla, Fdc Ltd, Gland Pharma Ltd, Micro Labs Ltd India, Mylan, Somerset Theraps Llc, USV, Watson Labs Inc, Wockhardt Ltd, Zambon Spa, Amneal, and Perrigo Israel, and is included in twenty-four NDAs. It is available from twenty-six 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 204812
Tradename:OLOPATADINE HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:olopatadine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204812
Suppliers and Packaging for NDA: 204812
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204812 ANDA WALGREEN CO. 0363-0200 0363-0200-40 1 BOTTLE, PLASTIC in 1 CARTON (0363-0200-40) > 5 mL in 1 BOTTLE, PLASTIC
OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204812 ANDA Amerisource Bergen 46122-672 46122-672-64 1 BOTTLE, PLASTIC in 1 CARTON (46122-672-64) > 5 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.1% BASE
Approval Date:Dec 18, 2015TE:ATRLD:No

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