Details for New Drug Application (NDA): 201507
✉ Email this page to a colleague
The generic ingredient in HYDROXYZINE PAMOATE is hydroxyzine pamoate. There are nineteen drug master file entries for this compound. Twenty-nine 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 |
Formulation / Manufacturing: | see details |
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 |
Complete Access Available with Subscription