Details for New Drug Application (NDA): 087408
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The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 087408
Tradename: | HYDROXYZINE HYDROCHLORIDE |
Applicant: | Am Regent |
Ingredient: | hydroxyzine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 087408
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 087408
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | INJECTABLE;INJECTION | 087408 | ANDA | Henry Schein, Inc. | 0404-9877 | 0404-9877-01 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9877-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | INJECTABLE;INJECTION | 087408 | ANDA | Henry Schein, Inc. | 0404-9878 | 0404-9878-02 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9878-02) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
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