Details for New Drug Application (NDA): 087871
✉ Email this page to a colleague
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 087871
Tradename: | HYDROXYZINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | hydroxyzine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 087871
Mechanism of Action | Histamine Receptor Antagonists |
Suppliers and Packaging for NDA: 087871
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 087871 | ANDA | Aurobindo Pharma Limited | 59651-499 | 59651-499-01 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-499-01) |
HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 087871 | ANDA | Aurobindo Pharma Limited | 59651-499 | 59651-499-05 | 500 TABLET, FILM COATED in 1 BOTTLE (59651-499-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Dec 20, 1982 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 20, 1982 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Dec 20, 1982 | TE: | AB | RLD: | No |
Complete Access Available with Subscription