Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083734
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROBENECID AND COLCHICINE | COLCHICINE; PROBENECID | 0.5MG;500MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/12/1978 | 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 |
|---|---|---|---|---|---|
| 07/29/2002 | SUPPL-47 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 03/12/2002 | SUPPL-46 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/11/2001 | SUPPL-44 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/28/2000 | SUPPL-43 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/11/2001 | SUPPL-42 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 07/11/2001 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/11/2001 | SUPPL-40 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/20/1999 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1998 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1997 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/03/1993 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1996 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/05/1990 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 01/20/1988 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/20/1988 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/20/1988 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/03/1987 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/03/1987 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |