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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 203152


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NDA 203152 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland Pharma Ltd, Glenmark Pharms Inc, Rising, Sciegen Pharms Inc, Somerset Theraps Llc, USV, Zambon Spa, Amneal, Apotex Inc, Hikma, and Padagis Israel, and is included in twenty-five NDAs. It is available from forty-one 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. Forty-three suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 203152
Tradename:OLOPATADINE HYDROCHLORIDE
Applicant:Usv
Ingredient:olopatadine hydrochloride
Patents:0
Pharmacology for NDA: 203152
Mechanism of ActionHistamine H1 Receptor Antagonists
Physiological EffectDecreased Histamine Release
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 Sola Pharmaceuticals 70512-520 70512-520-05 1 BOTTLE, PLASTIC in 1 CARTON (70512-520-05) / 5 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

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

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