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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021778
Company: ENDO OPERATIONS

Products on NDA 021778

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEGACE ES	MEGESTROL ACETATE	125MG/ML	SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021778

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/05/2005	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021778lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021778ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021778s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2018	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021778s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021778Orig1s024ltr.pdf
11/05/2015	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
10/16/2014	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
10/16/2014	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
09/18/2014	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021778s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021778Orig1s018ltr.pdf
07/31/2014	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/14/2013	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021778s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021778Orig1s016ltr.pdf
03/17/2014	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/14/2013	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
01/25/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/21/2010	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021778s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021778s008ltr.pdf
08/12/2008	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021778s007ltr.pdf
03/19/2007	SUPPL-3	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021778s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021778s002, 003ltr.pdf
03/19/2007	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021778s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021778s002, 003ltr.pdf

Labels for NDA 021778

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2018	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021778s024lbl.pdf
09/18/2014	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021778s018lbl.pdf
05/14/2013	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021778s016lbl.pdf
07/21/2010	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021778s008lbl.pdf
03/19/2007	SUPPL-3	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021778s002s003lbl.pdf
03/19/2007	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021778s002s003lbl.pdf
07/05/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021778lbl.pdf

Therapeutic Equivalents for NDA 021778

MEGACE ES

SUSPENSION;ORAL; 125MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEGACE ES	MEGESTROL ACETATE	125MG/ML	SUSPENSION;ORAL	Prescription	Yes	AB	021778	ENDO OPERATIONS
MEGESTROL ACETATE	MEGESTROL ACETATE	125MG/ML	SUSPENSION;ORAL	Prescription	No	AB	203139	TWI PHARMS

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