Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202245
Company: HIKMA
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 |
---|---|---|---|---|---|
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 |
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 |