Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/07/1988 | 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 |
|---|---|---|---|---|---|
| 02/20/2020 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2008 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 06/07/2001 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1999 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1999 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/25/1999 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1996 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1996 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 02/27/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1995 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1991 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 11/03/1989 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 06/13/1989 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 11/12/1985 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1985 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1985 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1983 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
ISOSORBIDE DINITRATE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ISORDIL | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 012093 | BAUSCH |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 086067 | HIKMA INTL PHARMS |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 086923 | PAR PHARM |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 215723 | RUBICON |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 086221 | SANDOZ |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 213057 | ZYDUS |