Details for New Drug Application (NDA): 204392
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NDA 204392 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, 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-six 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 204392
| Tradename: | OLOPATADINE HYDROCHLORIDE |
| Applicant: | Rising |
| Ingredient: | olopatadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204392
| Mechanism of Action | Histamine H1 Receptor Antagonists |
| Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 204392
Suppliers and Packaging for NDA: 204392
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204392 | ANDA | Rising Pharma Holdings, Inc. | 16571-882 | 16571-882-05 | 1 CONTAINER in 1 CARTON (16571-882-05) / 5 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.1% BASE | ||||
| Approval Date: | Mar 21, 2018 | TE: | RLD: | No | |||||
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