Details for New Drug Application (NDA): 204812
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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 204812
Tradename: | OLOPATADINE HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | olopatadine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 204812
Mechanism of Action | Histamine H1 Receptor Antagonists |
Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 204812
Suppliers and Packaging for NDA: 204812
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204812 | ANDA | WALGREEN CO. | 0363-0200 | 0363-0200-40 | 1 BOTTLE, PLASTIC in 1 CARTON (0363-0200-40) / 5 mL in 1 BOTTLE, PLASTIC |
OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204812 | ANDA | RITE AID CORPORATION | 11822-0064 | 11822-0064-1 | 1 BOTTLE, PLASTIC in 1 CARTON (11822-0064-1) / 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 18, 2015 | TE: | RLD: | No |
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