Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022207
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET;ORAL | Prescription | AB | Yes | No |
MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/17/2008 | ORIG-1 | Approval | Type 7 - Drug Already Marketed without Approved NDA | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022195,022207lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022195s000, 022207s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195_022207_morphine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195s000_022207s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/31/2024 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022207Orig1s013ltr.pdf |
12/15/2023 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022207s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022207Orig1s011ltr.pdf | |
03/04/2021 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022207Orig1s010ltr.pdf | |
10/07/2019 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022207s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022207Orig1s009ltr.pdf | |
09/18/2018 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022207Orig1s007s008ltr.pdf | |
09/18/2018 | SUPPL-7 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022207Orig1s007s008ltr.pdf | |
12/16/2016 | SUPPL-6 | Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022207Orig1s006ltr.pdf | |
06/02/2021 | SUPPL-5 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022195Orig1s010,%20022207Orig1s005ltr.pdf | |
01/23/2012 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022207s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022207s004ltr.pdf | |
04/15/2010 | SUPPL-2 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022207s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022207s011lbl.pdf | |
06/02/2021 | SUPPL-5 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s005lbl.pdf | |
03/04/2021 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s010lbl.pdf | |
10/07/2019 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022207s009lbl.pdf | |
10/07/2019 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022207s009lbl.pdf | |
09/18/2018 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf | |
09/18/2018 | SUPPL-7 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf | |
12/16/2016 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf | |
12/16/2016 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf | |
12/16/2016 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf | |
01/23/2012 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022207s004lbl.pdf | |
03/17/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022195,022207lbl.pdf |
MORPHINE SULFATE
TABLET;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET;ORAL | Prescription | No | AB | 212451 | ALKEM LABS LTD |
MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET;ORAL | Prescription | Yes | AB | 022207 | HIKMA |
MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET;ORAL | Prescription | No | AB | 215194 | SPECGX LLC |
MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET;ORAL | Prescription | No | AB | 210610 | UPSHER SMITH LABS |
TABLET;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET;ORAL | Prescription | No | AB | 212451 | ALKEM LABS LTD |
MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET;ORAL | Prescription | Yes | AB | 022207 | HIKMA |
MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET;ORAL | Prescription | No | AB | 215194 | SPECGX LLC |
MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET;ORAL | Prescription | No | AB | 210610 | UPSHER SMITH LABS |