Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085128
Company: TEVA

Products on ANDA 85128

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADIPEX-P	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET;ORAL	Prescription	AA	Yes	Yes

Labels for ANDA 085128

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2012	SUPPL-65	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf