Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 206544
Company: OHEMO LIFE
Company: OHEMO LIFE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MORPHABOND ER | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
MORPHABOND ER | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
MORPHABOND ER | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
MORPHABOND ER | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
10/02/2015 | 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/2015/206544lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206544Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206544Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206544Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/07/2019 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206544s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206544Orig1s012ltr.pdf | |
09/18/2018 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206544Orig1s008s010ltr.pdf | |
12/31/2018 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206544Orig1s009ltr.pdf | |
09/18/2018 | SUPPL-8 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206544Orig1s008s010ltr.pdf | |
06/01/2018 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206544Orig1s007ltr.pdf | |
05/26/2017 | SUPPL-6 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206544Orig1s006ltr.pdf |
12/16/2016 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s002,s005ltr.pdf | |
09/30/2016 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s004ltr.pdf |
12/16/2016 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s002,s005ltr.pdf | |
04/20/2016 | SUPPL-1 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/07/2019 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206544s012lbl.pdf | |
10/07/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206544s012lbl.pdf | |
12/31/2018 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s009lbl.pdf | |
09/18/2018 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf | |
09/18/2018 | SUPPL-8 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf | |
06/01/2018 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s007lbl.pdf | |
12/16/2016 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf | |
12/16/2016 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf | |
12/16/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf | |
10/02/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206544lbl.pdf |