Drugs@FDA: FDA-Approved Drugs
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. |
||
03/12/2002 | SUPPL-46 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/11/2001 | SUPPL-44 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
01/28/2000 | SUPPL-43 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/11/2001 | SUPPL-42 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
07/11/2001 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/11/2001 | SUPPL-40 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
08/20/1999 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/09/1998 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/1997 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/03/1993 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/05/1996 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/05/1990 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
01/20/1988 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/20/1988 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/20/1988 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/03/1987 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/03/1987 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |