Home Applications 040841 Application 040841
Type ANDA
Sponsor NORTHSTAR HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog .
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 8 of 8 · 148 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydroxyzine Hydrochloride HYDROXYZINE HYDROCHLORIDE KVK-Tech, Inc. adc4cb73-77c6-48ff-aaf2-b3568d53de1f 2023-01-04 Warnings, Adverse reactions Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE Hydroxyzine Hydrochloride HYDROXYZINE HYDROCHLORIDE Camber Pharmaceuticals, Inc. f7e527fe-2f67-45ad-a3ec-146ead819514 2022-11-24 Warnings, Adverse reactions Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE Hydroxyzine Hydrochloride HYDROXYZINE HYDROCHLORIDE Proficient Rx LP 3edfac5c-a08b-4270-a343-9b2dc10a4a6e 2022-11-01 Warnings, Adverse reactions Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE Hydroxyzine Hydrochloride HYDROXYZINE HYDROCHLORIDE Proficient Rx LP 642ff329-c551-44f0-b340-49313db868c5 2022-11-01 Warnings, Adverse reactions Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE Hydroxyzine Hydrochloride HYDROXYZINE HYDROCHLORIDE Proficient Rx LP daefb617-209a-428b-9567-adc5880fa65c 2022-11-01 Warnings, Adverse reactions Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE Hydroxyzine Hydrochloride HYDROXYZINE HYDROCHLORIDE Proficient Rx LP bcddc5ce-6cfb-4a09-8e6c-c956b65e3188 2022-10-01 Warnings, Adverse reactions Name fallback brand name: Hydroxyzine Hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE Hydroxyzine hydrochloride HYDROXYZINE HYDROCHLORIDE Proficient Rx LP 73993c7e-acd7-4835-be03-f8274a15955b 2022-06-01 Warnings, Adverse reactions Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE Hydroxyzine hydrochloride HYDROXYZINE HYDROCHLORIDE Proficient Rx LP 2da6dd2f-90e2-464a-ad2a-292575cb0428 2022-05-02 Warnings, Adverse reactions Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.