Details for New Drug Application (NDA): 213757
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The generic ingredient in OLOPATADINE HYDROCHLORIDE is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 213757
Tradename: | OLOPATADINE HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | olopatadine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213757
Mechanism of Action | Histamine H1 Receptor Antagonists |
Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 213757
Suppliers and Packaging for NDA: 213757
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 213757 | ANDA | Akorn | 50383-943 | 50383-943-23 | 1 BOTTLE in 1 CARTON (50383-943-23) / 240 SPRAY, METERED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | 0.665MG/SPRAY | ||||
Approval Date: | Aug 19, 2020 | TE: | RLD: | No |
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