Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022402
Company: HIKMA

• Medication Guide

• REMS

• Summary Review

Products on NDA 22402

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CODEINE SULFATE	CODEINE SULFATE	15MG	TABLET;ORAL	Prescription	AB	Yes	No
CODEINE SULFATE	CODEINE SULFATE	30MG	TABLET;ORAL	Prescription	AB	Yes	No
CODEINE SULFATE	CODEINE SULFATE	60MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 022402

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022402s015lbl.pdf
03/04/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022402s014lbl.pdf
10/07/2019	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022402s012lbl.pdf
10/07/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022402s012lbl.pdf
09/18/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf
09/18/2018	SUPPL-10	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf
08/29/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022402s009lbl.pdf
12/16/2016	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022402s008lbl.pdf
12/16/2016	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022402s008lbl.pdf
05/09/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022402s006lbl.pdf
04/17/2012	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022402s003lbl.pdf
07/16/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022402s000lbl.pdf