Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202245
Company: HIKMA
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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