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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020264
Company: BRISTOL MYERS SQUIBB

Products on NDA 020264

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MEGACE	MEGESTROL ACETATE	40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020264

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.

Labels for NDA 020264

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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