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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020843
Company: VIRTUS PHARMS

Products on NDA 020843

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020843

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		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.html

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.

Labels for NDA 020843

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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