Details for New Drug Application (NDA): 090870
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The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the epinastine hydrochloride profile page.
Summary for 090870
Tradename: | EPINASTINE HYDROCHLORIDE |
Applicant: | Breckenridge |
Ingredient: | epinastine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090870
Mechanism of Action | Adrenergic Agonists Histamine H1 Receptor Antagonists |
Physiological Effect | Decreased Histamine Release |
Suppliers and Packaging for NDA: 090870
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPINASTINE HYDROCHLORIDE | epinastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 090870 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-836 | 51991-836-75 | 1 BOTTLE, DROPPER in 1 CARTON (51991-836-75) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.05% | ||||
Approval Date: | Mar 14, 2011 | TE: | AT | RLD: | No |
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