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 | 10MG | 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-50 | Labeling-Package Insert |
Label is not available on this site. |
||
02/21/2008 | SUPPL-45 | Labeling |
Label is not available on this site. |
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06/07/2001 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/22/1999 | SUPPL-40 | Labeling |
Label is not available on this site. |
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05/05/1999 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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03/11/1999 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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03/25/1999 | SUPPL-36 | Labeling |
Label is not available on this site. |
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03/25/1999 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/02/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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09/13/1996 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
02/27/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/20/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/21/1991 | SUPPL-30 | Labeling |
Label is not available on this site. |
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11/03/1989 | SUPPL-29 | Labeling |
Label is not available on this site. |
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06/13/1989 | SUPPL-28 | Labeling |
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. |
||
03/25/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/25/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/25/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/25/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/25/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/25/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/25/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
ISOSORBIDE DINITRATE
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 086066 | HIKMA INTL PHARMS |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 086925 | PAR PHARM |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 215723 | RUBICON |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 086223 | SANDOZ |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 213057 | ZYDUS |