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Last Updated: August 3, 2021

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Details for New Drug Application (NDA): 204392

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NDA 204392 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Akorn, 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-five NDAs. It is available from thirty-seven 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 204392
Ingredient:olopatadine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 204392
Suppliers and Packaging for NDA: 204392
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204392 ANDA Mylan Pharmaceuticals Inc. 0378-8023 0378-8023-35 1 BOTTLE, DROPPER in 1 CARTON (0378-8023-35) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.1% BASE
Approval Date:Mar 21, 2018TE:RLD:No

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