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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016848
Company: MYLAN SPECIALITY LP

Products on NDA 016848

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANADROL-50	OXYMETHOLONE	50MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016848

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/1972	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2014	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
08/25/2004	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16848s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16848s021ltr.pdf
11/17/2003	SUPPL-20	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16848slr020ltr.pdf
02/06/2002	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/14/1997	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
06/09/1994	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
07/15/1993	SUPPL-16	Labeling		Label is not available on this site.
02/18/1992	SUPPL-15	Labeling		Label is not available on this site.
08/24/1992	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
07/15/1993	SUPPL-13	Labeling		Label is not available on this site.
08/14/1991	SUPPL-12	Labeling		Label is not available on this site.
01/26/1990	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
08/25/1986	SUPPL-10	Labeling		Label is not available on this site.
01/18/1983	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
04/15/1980	SUPPL-6	Labeling		Label is not available on this site.
06/15/1976	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/10/1975	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 016848

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/25/2004	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16848s021lbl.pdf

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