Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017063
Company: ALCON
Company: ALCON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISMOTIC | ISOSORBIDE | 100GM/220ML | SOLUTION;ORAL | 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 |
---|---|---|---|---|---|---|---|
01/30/1974 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/07/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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05/05/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
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07/13/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
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03/04/1988 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/07/1981 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/10/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
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01/09/1980 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/12/1978 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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08/25/1975 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |