Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072410
Company: INWOOD LABS
Company: INWOOD LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDOMETHACIN | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 03/15/1989 | 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 |
|---|---|---|---|---|---|
| 04/15/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/05/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/02/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/09/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 11/09/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 07/28/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/15/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |