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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022057
Company: FERRING

Products on NDA 022057

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENDOMETRIN	PROGESTERONE	100MG	INSERT;VAGINAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022057

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2007	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022057s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022057_endometrin_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/10/2016	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/07/2016	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/21/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/11/2013	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/08/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/03/2009	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022057s002ltr.pdf
02/26/2008	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022057s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022057s001ltr.pdf

Labels for NDA 022057

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2008	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022057s001lbl.pdf
06/21/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022057lbl.pdf

Therapeutic Equivalents for NDA 022057

ENDOMETRIN

INSERT;VAGINAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENDOMETRIN	PROGESTERONE	100MG	INSERT;VAGINAL	Prescription	Yes	AB	022057	FERRING
PROGESTERONE	PROGESTERONE	100MG	INSERT;VAGINAL	Prescription	No	AB	218391	XIROMED

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