Drugs@FDA: FDA Approved Drug Products

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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 Review

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) Label (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Label (PDF)
Letter (PDF)
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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20701slr012ltr.pdf
09/17/2003 SUPPL-11 Labeling Letter (PDF)

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 Letter (PDF)
Review (PDF)

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 Letter (PDF)

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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