Drugs@FDA: FDA-Approved Drugs
Company: HIKMA INTL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;SUBLINGUAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/02/1987 | 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 |
|---|---|---|---|---|---|
| 07/01/2002 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 05/01/2001 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 03/07/2001 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1997 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/02/1994 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 12/04/1992 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 03/27/1991 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 02/13/1991 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1993 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1993 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1993 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/16/1993 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1987 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1987 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1986 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |