Details for New Drug Application (NDA): 210901
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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 210901
Tradename: | OLOPATADINE HYDROCHLORIDE |
Applicant: | Amneal |
Ingredient: | olopatadine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210901
Mechanism of Action | Histamine H1 Receptor Antagonists |
Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 210901
Suppliers and Packaging for NDA: 210901
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 210901 | ANDA | Amneal Pharmaceuticals LLC | 65162-890 | 65162-890-23 | 1 BOTTLE, SPRAY in 1 CARTON (65162-890-23) / 665 SPRAY, METERED in 1 BOTTLE, SPRAY |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.665MG/SPRAY | ||||
Approval Date: | Jan 28, 2020 | TE: | AB | RLD: | No |
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