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
CERVIDIL از شرکت FERRING PHARMS INC
New Drug Application (NDA): 020411
Company: FERRING PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CERVIDIL | DINOPROSTONE | 10MG | INSERT, EXTENDED RELEASE;VAGINAL | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/30/1995 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 07/07/2020 | SUPPL-31 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020411Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020411Orig1s031ltr.pdf |
||
| 05/26/2010 | SUPPL-27 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020411s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020411s027ltr.pdf |
||
| 11/28/2006 | SUPPL-23 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020411s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020411s023ltr.pdf |
||
| 01/25/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/2000 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/30/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/27/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/31/1999 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/19/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/03/1998 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/24/1997 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1995 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/07/2020 | SUPPL-31 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020411Orig1s031lbl.pdf | |
| 05/26/2010 | SUPPL-27 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020411s027lbl.pdf | |
| 11/28/2006 | SUPPL-23 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020411s023lbl.pdf |
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