Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020843
Company: VIRTUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETRIUM PROGESTERONE 100MG CAPSULE; ORAL Prescription None No No
PROMETRIUM PROGESTERONE 200MG CAPSULE; ORAL Prescription None No No
PROMETRIUM PROGESTERONE 300MG CAPSULE; ORAL Prescription None No 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
12/16/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20843lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20843ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020843_s000_PrometriumTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2014 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/01/2011 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019781s017,020843s011ltr.pdf
06/30/2009 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020843s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019781s013,020843s010ltr.pdf
03/04/2004 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781slr008,20843slr008ltr.pdf
06/27/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/2004 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19781s005,006,20843s005,006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781s005,006,20843s005,006ltr.pdf
12/10/2004 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19781s005,006,20843s005,006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781s005,006,20843s005,006ltr.pdf
04/17/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/17/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/17/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/15/1999 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
11/01/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf
06/30/2009 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020843s010lbl.pdf
12/10/2004 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19781s005,006,20843s005,006lbl.pdf
12/10/2004 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19781s005,006,20843s005,006lbl.pdf
12/16/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20843lbl.pdf

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