Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072169
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 800MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/11/1987 | 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/26/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 06/30/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |