Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020264
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEGACE MEGESTROL ACETATE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/10/1993 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020264Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/18/2019 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020264s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020264Orig1s021ltr.pdf
05/02/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/08/2012 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020264s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020264s017ltr.pdf
05/01/2003 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20264slr011ltr.pdf
04/09/2002 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20264s9ltr.pdf
07/27/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/24/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/08/1997 SUPPL-4 Labeling

Label is not available on this site.

10/22/1996 SUPPL-3 Labeling

Label is not available on this site.

07/29/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1994 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/18/2019 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020264s021lbl.pdf
04/08/2012 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020264s017lbl.pdf

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