اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CLOMID از شرکت SANOFI AVENTIS US
New Drug Application (NDA): 016131
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| CLOMID | CLOMIPHENE CITRATE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |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 |
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 |
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. |
||
| 09/30/1994 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 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. |
||
| 11/18/1981 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 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 |
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