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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 three suppliers. Additional details are available on the VISTARIL profile page.

The generic ingredient in VISTARIL is hydroxyzine pamoate. There are nineteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the hydroxyzine pamoate profile page.

Summary for NDA: 011459

hydroxyzine pamoate
Therapeutic Class:Antiemetics
Respiratory Tract Agents

Pharmacology for NDA: 011459

Suppliers and Packaging for NDA: 011459

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydroxyzine pamoate
CAPSULE;ORAL 011459 NDA Pfizer Laboratories Div Pfizer Inc 0069-5410 0069-5410-66 100 CAPSULE in 1 BOTTLE (0069-5410-66)
hydroxyzine pamoate
CAPSULE;ORAL 011459 NDA Pfizer Laboratories Div Pfizer Inc 0069-5420 0069-5420-66 100 CAPSULE in 1 BOTTLE (0069-5420-66)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG HCL
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG HCL
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 100MG HCL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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