Details for New Drug Application (NDA): 011459
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The generic ingredient in VISTARIL 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 011459
Tradename: | VISTARIL |
Applicant: | Pfizer |
Ingredient: | hydroxyzine pamoate |
Patents: | 0 |
Pharmacology for NDA: 011459
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 011459
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VISTARIL | hydroxyzine pamoate | CAPSULE;ORAL | 011459 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-5410 | 0069-5410-66 | 100 CAPSULE in 1 BOTTLE (0069-5410-66) |
VISTARIL | hydroxyzine pamoate | CAPSULE;ORAL | 011459 | NDA AUTHORIZED GENERIC | Greenstone LLC | 59762-5420 | 59762-5420-1 | 100 CAPSULE in 1 BOTTLE (59762-5420-1) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG HYDROCHLORIDE | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG HYDROCHLORIDE | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 006
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
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