Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022057
Company: FERRING
Company: FERRING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENDOMETRIN | PROGESTERONE | 100MG | INSERT;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 |
---|---|---|---|---|---|---|---|
06/21/2007 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022057s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022057_endometrin_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/16/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/10/2016 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/07/2016 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/21/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/11/2013 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/08/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/03/2009 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022057s002ltr.pdf |
02/26/2008 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022057s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022057s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/26/2008 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022057s001lbl.pdf | |
06/21/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022057lbl.pdf |