Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016131
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOMID | CLOMIPHENE CITRATE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
02/01/1967 | 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 |
---|---|---|---|---|---|
12/18/2017 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016131s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016131Orig1s028ltr.pdf | |
10/22/2012 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016131s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/016131Orig1s026.pdf | |
12/10/2002 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/25/1995 | SUPPL-24 | Labeling |
Label is not available on this site. |
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09/30/1994 | SUPPL-23 | Labeling |
Label is not available on this site. |
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02/22/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/14/1991 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/27/1988 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/21/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
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11/18/1981 | SUPPL-15 | Labeling |
Label is not available on this site. |
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06/23/1980 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/23/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/18/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016131s028lbl.pdf | |
10/22/2012 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf |