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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009830
Company: BAUSCH

Products on NDA 009830

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESTINON	PYRIDOSTIGMINE BROMIDE	5MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009830

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/02/1955	ORIG-1	Approval	Type 3 - New Dosage Form	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
12/07/1999	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
07/26/2001	SUPPL-12	Labeling		Label is not available on this site.
11/07/1996	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
07/26/2001	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/09829s9lbl.pdf
10/27/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/12/1990	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
05/31/1985	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/16/1983	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
10/08/1980	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 009830

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2001	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/09829s9lbl.pdf

Therapeutic Equivalents for NDA 009830

MESTINON

INJECTABLE;INJECTION; 5MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MESTINON	PYRIDOSTIGMINE BROMIDE	5MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	009830	BAUSCH
REGONOL	PYRIDOSTIGMINE BROMIDE	5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	017398	SANDOZ

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