Details for New Drug Application (NDA): 215006
NDA 215006 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Gland, Glenmark Pharms, Regcon Holdings, Rising, Sciegen Pharms, Somerset, Somerset Theraps Llc, USV, Zambon Spa, Amneal, Apotex Inc, Hikma, and Padagis Israel, and is included in twenty-nine NDAs. It is available from forty-eight suppliers. Additional details are available on the OLOPATADINE HYDROCHLORIDE profile page.
The generic ingredient in OLOPATADINE HYDROCHLORIDE is olopatadine hydrochloride. There is one drug master file entry for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
The generic ingredient in OLOPATADINE HYDROCHLORIDE is olopatadine hydrochloride. There is one drug master file entry for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 215006
| Tradename: | OLOPATADINE HYDROCHLORIDE |
| Applicant: | Somerset |
| Ingredient: | olopatadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 215006
| Mechanism of Action | Histamine H1 Receptor Antagonists |
| Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 215006
Suppliers and Packaging for NDA: 215006
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 215006 | ANDA | Somerset Therapeutics, LLC | 70069-491 | 70069-491-01 | 1 BOTTLE, PLASTIC in 1 CARTON (70069-491-01) / 2.5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.2% BASE | ||||
| Approval Date: | Dec 18, 2024 | TE: | RLD: | No | |||||
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