Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040512
Company: ANI PHARMS

Products on ANDA 040512

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG	TABLET;ORAL	Prescription	AB	No	No
PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	30MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040512

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/08/2003	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/040512.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2005	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040512

PYRIDOSTIGMINE BROMIDE

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