Drugs@FDA: FDA Approved Drug Products
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROBENECID | PROBENECID | 500MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 01/13/1976 | 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 |
|---|---|---|---|---|---|
| 02/25/1998 | SUPPL-151 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1997 | SUPPL-150 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1996 | SUPPL-149 | Labeling |
Label is not available on this site. |
||
| 04/24/1996 | SUPPL-148 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1994 | SUPPL-147 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1990 | SUPPL-145 | Labeling |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-144 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1990 | SUPPL-143 | Labeling |
Label is not available on this site. |
||
| 05/18/1989 | SUPPL-142 | Labeling |
Label is not available on this site. |
||
| 04/26/1988 | SUPPL-141 | Labeling |
Label is not available on this site. |
||
| 01/15/1988 | SUPPL-140 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1986 | SUPPL-138 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/1984 | SUPPL-136 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-135 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1983 | SUPPL-134 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1983 | SUPPL-133 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1982 | SUPPL-132 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1982 | SUPPL-131 | Manufacturing (CMC) |
Label is not available on this site. |
PROBENECID
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROBALAN | PROBENECID | 500MG | TABLET;ORAL | Prescription | No | AB | 080966 | LANNETT |
| PROBENECID | PROBENECID | 500MG | TABLET;ORAL | Prescription | No | AB | 084211 | MYLAN |
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