Details for New Drug Application (NDA): 209420
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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 209420
Tradename: | OLOPATADINE HYDROCHLORIDE |
Applicant: | Alembic |
Ingredient: | olopatadine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 209420
Mechanism of Action | Histamine H1 Receptor Antagonists |
Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 209420
Suppliers and Packaging for NDA: 209420
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209420 | ANDA | Alembic Pharmaceuticals Limited | 46708-710 | 46708-710-03 | 1 BOTTLE in 1 CARTON (46708-710-03) / 2.5 mL in 1 BOTTLE |
OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209420 | ANDA | OCuSOFT INC. | 54799-920 | 54799-920-25 | 2.5 mL in 1 BOTTLE, PLASTIC (54799-920-25) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.2% BASE | ||||
Approval Date: | Apr 29, 2019 | TE: | RLD: | No |
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