Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021778
Company: ENDO PHARMS INC
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
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
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

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 PHARMS INC
MEGESTROL ACETATE MEGESTROL ACETATE 125MG/ML SUSPENSION;ORAL Prescription No AB 204688 BRECKENRIDGE
MEGESTROL ACETATE MEGESTROL ACETATE 125MG/ML SUSPENSION;ORAL Prescription No AB 203139 TWI PHARMS

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