Details for New Drug Application (NDA): 040808
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The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 040808
Tradename: | HYDROXYZINE HYDROCHLORIDE |
Applicant: | Amneal Pharm |
Ingredient: | hydroxyzine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040808
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 040808
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 040808 | ANDA | Amneal Pharmaceuticals LLC | 65162-575 | 65162-575-10 | 100 TABLET, FILM COATED in 1 BOTTLE (65162-575-10) |
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 040808 | ANDA | Amneal Pharmaceuticals LLC | 65162-575 | 65162-575-11 | 1000 TABLET, FILM COATED in 1 BOTTLE (65162-575-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 24, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Sep 24, 2008 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Sep 24, 2008 | TE: | AB | RLD: | No |
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