Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYTADREN | AMINOGLUTETHIMIDE | 250MG | TABLET;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 |
---|---|---|---|---|---|---|---|
10/29/1980 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/07/2003 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018202s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18202slr021ltr.pdf | |
05/13/2002 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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01/25/2002 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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08/01/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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04/23/1999 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/18/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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04/15/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
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03/23/1995 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/14/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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08/04/1992 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/27/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
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08/14/1984 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/09/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/16/1984 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/02/1981 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/02/1981 | SUPPL-3 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/07/2003 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018202s021lbl.pdf |