Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080212
Company: HIKMA INTL PHARMS
Company: HIKMA INTL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISONIAZID | ISONIAZID | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/28/1972 | 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 |
|---|---|---|---|---|---|
| 10/31/2008 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1997 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/23/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1995 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1995 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 06/23/1995 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1995 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/23/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |