Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070147
Company: PURACAP PHARM
Company: PURACAP PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALLOPURINOL | ALLOPURINOL | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/10/1985 | 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 |
|---|---|---|---|---|---|
| 07/29/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/13/2001 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/15/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/25/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |