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;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 |
---|---|---|---|---|---|---|---|
10/26/1987 | 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 |
---|---|---|---|---|---|
01/04/2016 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
01/04/2016 | SUPPL-45 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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09/26/2016 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
07/05/2002 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
04/11/2001 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/17/2000 | SUPPL-36 | Labeling |
Label is not available on this site. |
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03/07/2001 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/07/2001 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/01/1998 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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03/03/1997 | SUPPL-32 | Labeling |
Label is not available on this site. |
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04/12/1994 | SUPPL-31 | Labeling |
Label is not available on this site. |
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04/12/1994 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/04/1992 | SUPPL-29 | Labeling |
Label is not available on this site. |
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05/13/1991 | SUPPL-28 | Labeling |
Label is not available on this site. |
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02/13/1991 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1993 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
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06/16/1993 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/14/1988 | SUPPL-20 | Labeling |
Label is not available on this site. |
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05/15/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/15/1987 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/11/1984 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/10/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/28/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/10/1982 | SUPPL-10 | 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 | 086923 | ENDO OPERATIONS |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 086067 | HIKMA INTL PHARMS |
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 LIFESCIENCES |