Details for New Drug Application (NDA): 201674
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The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 201674
Tradename: | HYDROXYZINE HYDROCHLORIDE |
Applicant: | Lannett Co Inc |
Ingredient: | hydroxyzine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201674
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 201674
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | SYRUP;ORAL | 201674 | ANDA | Lannett Company, Inc. | 54838-502 | 54838-502-80 | 473 mL in 1 BOTTLE, PLASTIC (54838-502-80) |
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | SYRUP;ORAL | 201674 | ANDA | Chartwell RX, LLC | 62135-502 | 62135-502-47 | 473 mL in 1 BOTTLE (62135-502-47) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML | ||||
Approval Date: | Aug 21, 2013 | TE: | AA | RLD: | No |
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