Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213557
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
09/11/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CETIRIZINE HYDROCHLORIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 213557 | AUROBINDO PHARMA LTD |
CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 205490 | PERRIGO R AND D |
ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | Yes | 022578 | J AND J CONSUMER INC |