Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040432
Company: CHARTWELL

• REMS

Products on ANDA 40432

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET;ORAL	Prescription	AA	No	No

Labels for ANDA 040432

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf