Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208603
Company: ZYLA
Company: ZYLA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARYMO ER | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
ARYMO ER | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
ARYMO ER | MORPHINE SULFATE | 60MG | 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 |
---|---|---|---|---|---|---|---|
01/09/2017 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208603s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208603Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208603Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/07/2019 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208603s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208603Orig1s005ltr.pdf | |
09/18/2018 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208603Orig1s003s004ltr.pdf | |
09/18/2018 | SUPPL-3 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208603Orig1s003s004ltr.pdf | |
05/26/2017 | SUPPL-2 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208603Orig1s002ltr.pdf |
10/12/2018 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208603Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/07/2019 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208603s005lbl.pdf | |
10/07/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208603s005lbl.pdf | |
10/12/2018 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s001lbl.pdf | |
09/18/2018 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf | |
09/18/2018 | SUPPL-3 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf | |
01/09/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208603s000lbl.pdf |