Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073644
Company: CHARTWELL RX

• Other Important Information from FDA

Products on ANDA 73644

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIVACTIL	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET;ORAL	Discontinued	None	No	No

Labels for ANDA 073644

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2014	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/073645s028,073644s023lbl.pdf