Details for New Drug Application (NDA): 078350
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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 078350
Tradename: | OLOPATADINE HYDROCHLORIDE |
Applicant: | Apotex |
Ingredient: | olopatadine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078350
Mechanism of Action | Histamine H1 Receptor Antagonists |
Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 078350
Suppliers and Packaging for NDA: 078350
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 078350 | ANDA | Golden State Medical Supply, Inc. | 51407-663 | 51407-663-05 | 1 BOTTLE, PLASTIC in 1 CARTON (51407-663-05) / 5 mL in 1 BOTTLE, PLASTIC |
OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 078350 | ANDA | Apotex Corp. | 60505-6221 | 60505-6221-0 | 1 BOTTLE, PLASTIC in 1 CARTON (60505-6221-0) / 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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