Details for New Drug Application (NDA): 090951
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NDA 090951 describes EPINASTINE HYDROCHLORIDE, which is a drug marketed by Apotex, Breckenridge, Chartwell Rx, Epic Pharma Llc, Somerset Theraps Llc, and Sun Pharm Inds, and is included in six NDAs. It is available from one supplier. Additional details are available on the EPINASTINE HYDROCHLORIDE profile page.
The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinastine hydrochloride profile page.
The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinastine hydrochloride profile page.
Summary for 090951
| Tradename: | EPINASTINE HYDROCHLORIDE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | epinastine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 090951
| Mechanism of Action | Adrenergic Agonists Histamine H1 Receptor Antagonists |
| Physiological Effect | Decreased Histamine Release |
Suppliers and Packaging for NDA: 090951
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPINASTINE HYDROCHLORIDE | epinastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 090951 | ANDA | Somerset Therapeutics, LLC | 70069-008 | 70069-008-10 | 10 CARTON in 1 CARTON (70069-008-10) / 1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.05% | ||||
| Approval Date: | Oct 31, 2011 | TE: | AT | RLD: | No | ||||
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