Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079191
Company: TORRENT PHARMS LLC
Company: TORRENT PHARMS LLC
| 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 RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/15/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079191s000ltr.pdf |