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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212702
Company: AMNEAL

Products on ANDA 212702

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212702

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/10/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212702Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212702

PYRIDOSTIGMINE BROMIDE

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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