Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071448
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| 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 |
|---|---|---|---|---|---|---|---|
| 02/18/1987 | 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 |
|---|---|---|---|---|---|
| 11/21/2024 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2021 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2019 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/20/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/12/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/16/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |