Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213565
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 200MG;30MG | 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 |
---|---|---|---|---|---|---|---|
03/10/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |