Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020756
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CRINONE PROGESTERONE 8% GEL;VAGINAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/13/1997 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020756_crinone_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/17/2003 SUPPL-12 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-10 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20756S10ltr.pdf
04/03/2001 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20756S9ltr.pdf
12/16/1998 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/11/1998 SUPPL-6 Labeling

Label is not available on this site.

12/11/1997 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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