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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017871
Company: BAUSCH

Products on NDA 017871

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEMSER	METYROSINE	250MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017871

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/03/1979	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/15/2014	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
11/08/2013	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
05/30/2003	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17871slr011ltr.pdf
12/12/2001	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
03/16/1994	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/23/1987	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/07/1988	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
11/01/1985	SUPPL-6	Labeling		Label is not available on this site.
09/06/1985	SUPPL-5	Labeling		Label is not available on this site.
01/25/1984	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/14/1980	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.

Therapeutic Equivalents for NDA 017871

DEMSER

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEMSER	METYROSINE	250MG	CAPSULE;ORAL	Prescription	Yes	AB	017871	BAUSCH
METYROSINE	METYROSINE	250MG	CAPSULE;ORAL	Prescription	No	AB	213734	AMNEAL

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