Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022402
Company: HIKMA
Company: HIKMA
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 |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
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 |