Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040842
Company: NORTHSTAR HLTHCARE
Company: NORTHSTAR HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/31/2008 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/03/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
04/30/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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01/17/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
12/08/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
HYDROXYZINE HYDROCHLORIDE
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040808 | AMNEAL PHARM |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 087871 | AUROBINDO PHARMA LTD |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040804 | CHARTWELL RX |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040604 | EPIC PHARMA LLC |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 217652 | GRAVITI PHARMS |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 204279 | HERITAGE PHARMA |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040805 | HETERO LABS LTD III |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040786 | KVK TECH |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040840 | NORTHSTAR HLTHCARE |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040842 | NORTHSTAR HLTHCARE |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 207121 | NUVO PHARMS INC |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 088618 | PLIVA |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040580 | PRINSTON INC |