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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015193
Company: BAUSCH

Products on NDA 015193

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESTINON	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 015193

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/1965	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
10/29/2019	SUPPL-27	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/015193Orig1s027ltr.pdf
02/23/2015	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
09/26/2013	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
09/30/2014	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
05/22/2002	SUPPL-20	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/15193s020ltr.pdf
11/07/1996	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
07/26/2001	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf
10/27/1995	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/17/1993	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
01/27/1986	SUPPL-14	Labeling		Label is not available on this site.
02/04/1982	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 015193

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2001	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf

Therapeutic Equivalents for NDA 015193

MESTINON

SYRUP;ORAL; 60MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MESTINON	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP;ORAL	Prescription	Yes	AA	015193	BAUSCH
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP;ORAL	Prescription	No	AA	212702	AMNEAL
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP;ORAL	Prescription	No	AA	212405	MILLA PHARMS
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP;ORAL	Prescription	No	AA	216512	MSN
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP;ORAL	Prescription	No	AA	211694	NOVITIUM PHARMA
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP;ORAL	Prescription	No	AA	208797	RISING

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