Details for New Drug Application (NDA): 040156
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NDA 040156 describes HYDROXYZINE PAMOATE, which is a drug marketed by Barr, Beximco Pharms Usa, Duramed Pharms Barr, Heritage Pharma, Impax Labs Inc, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Superpharm, Vangard, and Watson Labs, and is included in thirty-four NDAs. It is available from twenty-nine suppliers. Additional details are available on the HYDROXYZINE PAMOATE profile page.
The generic ingredient in HYDROXYZINE PAMOATE is hydroxyzine pamoate. There are nineteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydroxyzine pamoate profile page.
The generic ingredient in HYDROXYZINE PAMOATE is hydroxyzine pamoate. There are nineteen drug master file entries for this compound. Thirty-one 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 |
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 | Amneal Pharmaceuticals of New York LLC | 0115-1803 | 0115-1803-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0115-1803-01) |
| HYDROXYZINE PAMOATE | hydroxyzine pamoate | CAPSULE;ORAL | 040156 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1803 | 0115-1803-02 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1803-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG HYDROCHLORIDE | ||||
| 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 HYDROCHLORIDE | ||||
| Approval Date: | Jul 15, 1996 | TE: | AB | RLD: | No | ||||
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