Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019429
Company: ALLERGAN

• Medication Guide

• Corrected Approval Letter

• REMS

Products on NDA 19429

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FIORINAL W/CODEINE	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	325MG;50MG;40MG;30MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Labels for NDA 019429

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019429s045lbl.pdf
04/28/2021	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019429s044s045lbl.pdf
10/07/2019	SUPPL-43	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf
10/07/2019	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf
09/18/2018	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf
09/18/2018	SUPPL-41	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf
08/29/2017	SUPPL-40	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019429s040lbl.pdf
08/29/2017	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019429s040lbl.pdf
12/16/2016	SUPPL-39	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf
12/16/2016	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf
12/16/2016	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf
05/09/2013	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019429s035lbl.pdf
04/08/2008	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019429s023lbl.pdf