Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201517
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 100MG/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 |
---|---|---|---|---|---|---|---|
06/23/2011 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201517s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201517s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201517_morphine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201517Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201517s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201517Orig1s018ltr.pdf | |
03/04/2021 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201517s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201517Orig1s017ltr.pdf | |
10/07/2019 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201517s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201517Orig1s015ltr.pdf | |
09/18/2018 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201517Orig1s012s013ltr.pdf | |
09/18/2018 | SUPPL-12 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201517Orig1s012s013ltr.pdf | |
12/16/2016 | SUPPL-9 | Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201517s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201517Orig1s009ltr.pdf | |
02/22/2016 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/09/2017 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/10/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201517s018lbl.pdf | |
12/15/2023 | SUPPL-18 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201517s018lbl.pdf | |
03/04/2021 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201517s017lbl.pdf | |
10/07/2019 | SUPPL-15 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201517s015lbl.pdf | |
10/07/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201517s015lbl.pdf | |
09/18/2018 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf | |
09/18/2018 | SUPPL-12 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf | |
12/16/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201517s009lbl.pdf | |
12/16/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201517s009lbl.pdf | |
12/16/2016 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201517s009lbl.pdf | |
06/23/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201517s000lbl.pdf |