Details for New Drug Application (NDA): 011459
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NDA 011459 describes VISTARIL, which is a drug marketed by Pfizer and is included in three NDAs. It is available from two suppliers. Additional details are available on the VISTARIL profile page.
The generic ingredient in VISTARIL 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.
The generic ingredient in VISTARIL 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 011459
| Tradename: | VISTARIL |
| Applicant: | Pfizer |
| Ingredient: | hydroxyzine pamoate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
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 | Pfizer Laboratories Div Pfizer Inc | 0069-5420 | 0069-5420-66 | 100 CAPSULE in 1 BOTTLE (0069-5420-66) |
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CAPSULE;ORAL | Strength | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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