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 | 2.5MG | 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 |
---|---|---|---|---|---|---|---|
10/29/1987 | 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-41 | Labeling |
Label is not available on this site. |
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04/03/2001 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/31/2000 | SUPPL-39 | Labeling |
Label is not available on this site. |
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10/01/1998 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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03/03/1997 | SUPPL-37 | Labeling |
Label is not available on this site. |
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07/06/1994 | SUPPL-36 | Labeling |
Label is not available on this site. |
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12/04/1992 | SUPPL-35 | Labeling |
Label is not available on this site. |
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03/27/1991 | SUPPL-34 | Labeling |
Label is not available on this site. |
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02/13/1991 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1993 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1993 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1993 | SUPPL-30 | Labeling |
Label is not available on this site. |
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07/18/1991 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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08/25/1988 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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08/24/1988 | SUPPL-26 | Labeling |
Label is not available on this site. |
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08/25/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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08/25/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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01/07/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1984 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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08/10/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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08/10/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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07/23/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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08/10/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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08/10/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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03/10/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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03/10/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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03/10/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |