Drugs@FDA: FDA-Approved Drugs
Company: ROCHE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FANSIDAR | PYRIMETHAMINE; SULFADOXINE | 25MG;500MG | 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 |
---|---|---|---|---|---|---|---|
10/28/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | 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 |
---|---|---|---|---|---|
04/27/2003 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18557slr016ltr.pdf |
02/26/2004 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18557slr015_fansidar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18557slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018557_S015_Fandsidar_APPROVAL PACKAGE.pdf | |
08/14/1998 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/09/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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11/03/1987 | SUPPL-12 | Labeling |
Label is not available on this site. |
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04/30/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
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07/24/1985 | SUPPL-10 | Labeling |
Label is not available on this site. |
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07/24/1985 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/24/1985 | SUPPL-8 | Labeling |
Label is not available on this site. |
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07/24/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
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10/26/1983 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/26/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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07/21/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/21/1983 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/26/2004 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18557slr015_fansidar_lbl.pdf |