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Details for New Drug Application (NDA): 040156
The generic ingredient in HYDROXYZINE PAMOATE 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 040156
Tradename: | HYDROXYZINE PAMOATE |
Applicant: | Impax Labs Inc |
Ingredient: | hydroxyzine pamoate |
Patents: | 0 |
Therapeutic Class: | Antiemetics Respiratory Tract Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040156
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 040156
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE PAMOATE | hydroxyzine pamoate | CAPSULE;ORAL | 040156 | ANDA | Impax Generics | 0115-1670 | N | 0115-1670-01 |
HYDROXYZINE PAMOATE | hydroxyzine pamoate | CAPSULE;ORAL | 040156 | ANDA | Impax Generics | 0115-1670 | N | 0115-1670-02 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG HCL | ||||
Approval Date: | Jul 15, 1996 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG HCL | ||||
Approval Date: | Jul 15, 1996 | TE: | AB | RLD: | No |
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