Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018060
Company: COSETTE

Products on NDA 18060

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACEPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY;RECTAL	Discontinued	None	No	No
ACEPHEN	ACETAMINOPHEN	650MG	SUPPOSITORY;RECTAL	Discontinued	None	No	No
ACEPHEN	ACETAMINOPHEN	325MG	SUPPOSITORY;RECTAL	Discontinued	None	No	No

Labels for NDA 018060

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/25/2014	SUPPL-66	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018060Orig1s066lbl.pdf