Details for New Drug Application (NDA): 040604
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The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 040604
Tradename: | HYDROXYZINE HYDROCHLORIDE |
Applicant: | Epic Pharma Llc |
Ingredient: | hydroxyzine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040604
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 040604
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 040604 | ANDA | Major Pharmaceuticals | 0904-6617 | 0904-6617-61 | 100 BLISTER PACK in 1 CARTON (0904-6617-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 040604 | ANDA | Major Pharmaceuticals | 0904-6618 | 0904-6618-61 | 100 BLISTER PACK in 1 CARTON (0904-6618-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Dec 28, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 28, 2004 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Dec 28, 2004 | TE: | AB | RLD: | No |
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