Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDO-LEMMON | INDOMETHACIN | 50MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 11/07/1985 | 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 |
|---|---|---|---|---|---|
| 08/30/2001 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1995 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/26/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/26/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/26/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/01/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/10/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 06/30/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 02/22/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 03/23/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/23/1990 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |