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-two 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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