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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083976
Company: BAUSCH

Products on ANDA 083976

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTRED	METHYLTESTOSTERONE	10MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083976

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/1973	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2016	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
05/11/2015	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/083976s032lbl.pdf
06/19/2014	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/083976s031lbl.pdf
11/27/2002	SUPPL-27	Labeling		Label is not available on this site.
08/18/1998	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
08/25/1997	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
08/25/1997	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
08/08/1994	SUPPL-23	Labeling		Label is not available on this site.
11/03/1992	SUPPL-22	Labeling		Label is not available on this site.
05/29/1992	SUPPL-21	Labeling		Label is not available on this site.
05/25/1989	SUPPL-20	Labeling		Label is not available on this site.
03/08/1983	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 083976

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2015	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/083976s032lbl.pdf
06/19/2014	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/083976s031lbl.pdf

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