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
CRINONE از شرکت ALLERGAN
New Drug Application (NDA): 020701
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CRINONE | PROGESTERONE | 4% | GEL;VAGINAL | Prescription |
None |
Yes | Yes |
| CRINONE | PROGESTERONE | 8% | GEL;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 |
|---|---|---|---|---|---|---|---|
| 07/31/1997 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020701_crinone_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/2013 | SUPPL-26 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020701s026lbl.pdf |
||
| 09/29/2015 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/2011 | SUPPL-23 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020701s020s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020701s020,s021,s023ltr.pdf |
||
| 12/08/2011 | SUPPL-21 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020701s020s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020701s020,s021,s023ltr.pdf |
||
| 12/08/2011 | SUPPL-20 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020701s020s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020701s020,s021,s023ltr.pdf |
||
| 03/23/2005 | SUPPL-14 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20701s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20701s014ltr.pdf |
||
| 11/12/2003 | SUPPL-12 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20701slr012ltr.pdf |
|
| 09/17/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20701slr011,20756slr012ltr.pdf |
|
| 04/20/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20701S9ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020701_S009_CRINONE.pdf |
|
| 04/03/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001//20701S7ltr.pdf |
|
| 12/16/1998 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/11/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/11/1997 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/17/1998 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 08/21/2013 | SUPPL-26 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020701s026lbl.pdf |
| 12/08/2011 | SUPPL-23 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020701s020s021s023lbl.pdf | |
| 12/08/2011 | SUPPL-21 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020701s020s021s023lbl.pdf | |
| 12/08/2011 | SUPPL-20 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020701s020s021s023lbl.pdf | |
| 03/23/2005 | SUPPL-14 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20701s014lbl.pdf |
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