Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078680
Company: UNICHEM
Company: UNICHEM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
06/26/2009 | 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 |
---|---|---|---|---|---|
03/03/2020 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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07/23/2010 | SUPPL-1 | Labeling |
Label is not available on this site. |