Details for New Drug Application (NDA): 088618
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The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 088618
Tradename: | HYDROXYZINE HYDROCHLORIDE |
Applicant: | Pliva |
Ingredient: | hydroxyzine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 088618
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 088618
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 088618 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5061 | 0093-5061-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-5061-01) |
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 088618 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5061 | 0093-5061-05 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-5061-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jan 10, 1986 | TE: | AB | RLD: | Yes |
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