An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.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.

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

Top