Details for New Drug Application (NDA): 202853
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The generic ingredient in OLOPATADINE HYDROCHLORIDE is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 202853
Tradename: | OLOPATADINE HYDROCHLORIDE |
Applicant: | Padagis Israel |
Ingredient: | olopatadine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202853
Mechanism of Action | Histamine H1 Receptor Antagonists |
Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 202853
Suppliers and Packaging for NDA: 202853
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 202853 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-104 | 45802-104-01 | 1 BOTTLE in 1 CARTON (45802-104-01) / 240 SPRAY in 1 BOTTLE |
OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 202853 | ANDA | Bryant Ranch Prepack | 63629-8434 | 63629-8434-1 | 1 BOTTLE in 1 CARTON (63629-8434-1) / 240 SPRAY in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.665MG/SPRAY | ||||
Approval Date: | Jan 31, 2017 | TE: | AB | RLD: | No |
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