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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009829
Company: BAUSCH

Products on NDA 009829

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESTINON	PYRIDOSTIGMINE BROMIDE	60MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009829

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/1955	ORIG-1	Approval	Type 1 - New Molecular Entity	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
05/16/2014	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
01/09/2014	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/20/2000	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/30/1999	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/10/1997	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
11/07/1996	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
07/26/2001	SUPPL-11	Labeling		Label is not available on this site.
10/24/1995	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/26/2001	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf
01/27/1986	SUPPL-7	Labeling		Label is not available on this site.
02/18/1981	SUPPL-5	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 009829

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2001	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf

Therapeutic Equivalents for NDA 009829

MESTINON

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MESTINON	PYRIDOSTIGMINE BROMIDE	60MG	TABLET;ORAL	Prescription	Yes	AB	009829	BAUSCH
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG	TABLET;ORAL	Prescription	No	AB	040512	ANI PHARMS
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG	TABLET;ORAL	Prescription	No	AB	040502	IMPAX LABS
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG	TABLET;ORAL	Prescription	No	AB	211181	MLV
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG	TABLET;ORAL	Prescription	No	AB	205650	ZYDUS PHARMS

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