Details for New Drug Application (NDA): 206306
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NDA 206306 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.
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 206306
| Tradename: | OLOPATADINE HYDROCHLORIDE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | olopatadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 206306
| Mechanism of Action | Histamine H1 Receptor Antagonists |
| Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 206306
Suppliers and Packaging for NDA: 206306
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 206306 | ANDA | RPK Pharmaceuticals, Inc. | 53002-0510 | 53002-0510-1 | 5 mL in 1 BOTTLE, DROPPER (53002-0510-1) |
| OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 206306 | ANDA | Somerset Therapeutics, LLC | 70069-017 | 70069-017-01 | 1 BOTTLE, PLASTIC in 1 CARTON (70069-017-01) / 5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.1% BASE | ||||
| Approval Date: | Dec 7, 2015 | TE: | RLD: | No | |||||
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