Details for New Drug Application (NDA): 213514
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NDA 213514 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland, Glenmark Pharms, Rising, Sciegen Pharms, Somerset, Somerset Theraps Llc, USV, Zambon Spa, Amneal, Apotex Inc, Hikma, and Padagis Israel, and is included in twenty-nine NDAs. It is available from forty-seven suppliers. Additional details are available on the OLOPATADINE HYDROCHLORIDE profile page.
The generic ingredient in OLOPATADINE HYDROCHLORIDE is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
The generic ingredient in OLOPATADINE HYDROCHLORIDE is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 213514
| Tradename: | OLOPATADINE HYDROCHLORIDE |
| Applicant: | Gland |
| Ingredient: | olopatadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 213514
| Mechanism of Action | Histamine H1 Receptor Antagonists |
| Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 213514
Suppliers and Packaging for NDA: 213514
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 213514 | ANDA | Walgreen Company | 0363-1325 | 0363-1325-01 | 1 BOTTLE in 1 CARTON (0363-1325-01) / 2.5 mL in 1 BOTTLE |
| OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 213514 | ANDA | Walgreen Company | 0363-1325 | 0363-1325-02 | 2 BOTTLE in 1 CARTON (0363-1325-02) / 2.5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.7% BASE | ||||
| Approval Date: | Jan 6, 2026 | TE: | RLD: | No | |||||
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