Details for New Drug Application (NDA): 209919
✉ Email this page to a colleague
NDA 209919 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 Inc, Rising, Sciegen Pharms Inc, Somerset, Somerset Theraps Llc, USV, Zambon Spa, Amneal, Apotex Inc, Hikma, and Padagis Israel, and is included in twenty-eight NDAs. It is available from forty-five 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-six 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-six suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 209919
| Tradename: | OLOPATADINE HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | olopatadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 209919
| Mechanism of Action | Histamine H1 Receptor Antagonists |
| Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 209919
Suppliers and Packaging for NDA: 209919
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209919 | ANDA | Alembic Pharmaceuticals Limited | 46708-709 | 46708-709-05 | 1 BOTTLE in 1 CARTON (46708-709-05) / 5 mL in 1 BOTTLE |
| OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209919 | ANDA | Alembic Pharmaceuticals Inc. | 62332-501 | 62332-501-05 | 1 BOTTLE, PLASTIC in 1 CARTON (62332-501-05) / 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, 2018 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
