Details for New Drug Application (NDA): 207121
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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 207121
Tradename: | HYDROXYZINE HYDROCHLORIDE |
Applicant: | Nuvo Pharms Inc |
Ingredient: | hydroxyzine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207121
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 207121
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 207121 | ANDA | Sunrise Pharmaceutical, Inc. | 11534-204 | 11534-204-01 | 100 TABLET, FILM COATED in 1 BOTTLE (11534-204-01) |
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 207121 | ANDA | Sunrise Pharmaceutical, Inc. | 11534-204 | 11534-204-03 | 1000 TABLET, FILM COATED in 1 BOTTLE (11534-204-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Mar 29, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 29, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 29, 2017 | TE: | AB | RLD: | No |
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