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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202245
Company: HIKMA

Medication Guide

REMS

Summary Review

Products on NDA 202245

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CODEINE SULFATE	CODEINE SULFATE	30MG/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202245

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202245s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202245s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202245_codeine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202245Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202245s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202245Orig1s010ltr.pdf
03/04/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202245s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202245Orig1s009ltr.pdf
10/07/2019	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202245s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202245Orig1s008ltr.pdf
09/18/2018	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202245s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202245Orig1s006s007ltr.pdf
09/18/2018	SUPPL-6	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202245s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202245Orig1s006s007ltr.pdf
08/29/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202245s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202245Orig1s005ltr.pdf
12/16/2016	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202245s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202245Orig1s004ltr.pdf
05/09/2013	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202245s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202245Orig1s002ltr.pdf
04/17/2012	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202245s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202245s001ltr.pdf

Labels for NDA 202245

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202245s010lbl.pdf
03/04/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202245s009lbl.pdf
10/07/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202245s008lbl.pdf
10/07/2019	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202245s008lbl.pdf
09/18/2018	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202245s006s007lbl.pdf
09/18/2018	SUPPL-6	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202245s006s007lbl.pdf
08/29/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202245s005lbl.pdf
12/16/2016	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202245s004lbl.pdf
12/16/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202245s004lbl.pdf
05/09/2013	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202245s002lbl.pdf
04/17/2012	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202245s001lbl.pdf
06/30/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202245s000lbl.pdf

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