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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020701
Company: ALLERGAN

Products on NDA 020701

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020701

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.

Labels for NDA 020701

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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