Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089367
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 20MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/07/1988 | 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-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2008 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/07/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1999 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/25/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/27/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/03/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/19/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |
ISOSORBIDE DINITRATE
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 20MG | TABLET;ORAL | Prescription | No | AB | 088088 | HIKMA INTL PHARMS |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 20MG | TABLET;ORAL | Prescription | No | AB | 087537 | PAR PHARM |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 20MG | TABLET;ORAL | Prescription | No | AB | 215723 | RUBICON |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 20MG | TABLET;ORAL | Prescription | No | AB | 089367 | SANDOZ |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 20MG | TABLET;ORAL | Prescription | No | AB | 213057 | ZYDUS |