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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022402
Company: HIKMA

Medication Guide

REMS

Summary Review

Products on NDA 022402

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022402

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2009	ORIG-1	Approval	Type 7 - Drug Already Marketed without Approved NDA	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022402s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022402s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022402_codeine_sulfate_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022402s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2024	SUPPL-16	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022402Orig1s016ltr.pdf
12/15/2023	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022402s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022402Orig1s015ltr.pdf
03/04/2021	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022402s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022402Orig1s014ltr.pdf
10/07/2019	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022402s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022402Orig1s012ltr.pdf
09/18/2018	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022402Orig1s010s011ltr.pdf
09/18/2018	SUPPL-10	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022402Orig1s010s011ltr.pdf
08/29/2017	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022402s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022402Orig1s009ltr.pdf
12/16/2016	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022402s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022402Orig1s008ltr.pdf
05/09/2013	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022402s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022402Orig1s006ltr.pdf
06/17/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/17/2012	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022402s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022402s003ltr.pdf

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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022402s008lbl.pdf
12/16/2016	SUPPL-8	Labeling-Package Insert	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

Therapeutic Equivalents for NDA 022402

CODEINE SULFATE

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CODEINE SULFATE	CODEINE SULFATE	15MG	TABLET;ORAL	Prescription	Yes	AB	022402	HIKMA
CODEINE SULFATE	CODEINE SULFATE	15MG	TABLET;ORAL	Prescription	No	AB	203046	LANNETT CO INC

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CODEINE SULFATE	CODEINE SULFATE	30MG	TABLET;ORAL	Prescription	Yes	AB	022402	HIKMA
CODEINE SULFATE	CODEINE SULFATE	30MG	TABLET;ORAL	Prescription	No	AB	203046	LANNETT CO INC

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CODEINE SULFATE	CODEINE SULFATE	60MG	TABLET;ORAL	Prescription	Yes	AB	022402	HIKMA
CODEINE SULFATE	CODEINE SULFATE	60MG	TABLET;ORAL	Prescription	No	AB	203046	LANNETT CO INC

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