Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076478
Company: PERRIGO
Company: PERRIGO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 100MG/5ML;15MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 11/05/2003 | 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 |
|---|---|---|---|---|---|
| 03/30/2012 | SUPPL-30 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 03/30/2012 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 03/22/2006 | SUPPL-15 | Labeling |
Label is not available on this site. |