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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203184
Company: IMPAX LABS INC

Products on ANDA 203184

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203184

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2015	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203184

PYRIDOSTIGMINE BROMIDE

TABLET, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MESTINON	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	011665	BAUSCH
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204737	ALVOGEN
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203184	IMPAX LABS INC
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205464	RISING

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