Details for New Drug Application (NDA): 201507
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NDA 201507 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-eight 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 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 suppliers are listed for this compound. Additional details are available on the hydroxyzine pamoate profile page.
Summary for 201507
| Tradename: | HYDROXYZINE PAMOATE |
| Applicant: | Heritage Pharma |
| Ingredient: | hydroxyzine pamoate |
| Patents: | 0 |
Pharmacology for NDA: 201507
| Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 201507
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROXYZINE PAMOATE | hydroxyzine pamoate | CAPSULE;ORAL | 201507 | ANDA | Major Pharmaceuticals | 0904-7065 | 0904-7065-61 | 100 BLISTER PACK in 1 CARTON (0904-7065-61) / 1 CAPSULE in 1 BLISTER PACK |
| HYDROXYZINE PAMOATE | hydroxyzine pamoate | CAPSULE;ORAL | 201507 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 14539-674 | 14539-674-01 | 100 CAPSULE in 1 CONTAINER (14539-674-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG HYDROCHLORIDE | ||||
| Approval Date: | Jun 3, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG HYDROCHLORIDE | ||||
| Approval Date: | Jun 3, 2013 | TE: | AB | RLD: | No | ||||
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