Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018565
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DURAMORPH PF | MORPHINE SULFATE | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DURAMORPH PF | MORPHINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| INFUMORPH | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| INFUMORPH | MORPHINE SULFATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 09/18/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/018565s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/018565Orig1s036ltr.pdf | |
| 12/22/2025 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/018565s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/018565Orig1s035ltr.pdf | |
| 12/15/2023 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s027,s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018565Orig1s027; s031ltr.pdf | |
| 12/15/2023 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s028s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018565Orig1s028, s030ltr.pdf | |
| 11/08/2023 | SUPPL-29 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018565Orig1s029ltr.pdf | |
| 12/15/2023 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s028s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018565Orig1s028, s030ltr.pdf | |
| 12/15/2023 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s027,s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018565Orig1s027; s031ltr.pdf | |
| 10/07/2019 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018565s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018565Orig1s024ltr.pdf | |
| 12/16/2016 | SUPPL-22 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) |
DURAMORPH & INFUMORPH have separate letters and labels | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Duramorph.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Infumorph.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018565Orig1s022ltr_Duramorph.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018565Orig1s022ltr_Infumorph.pdf |
| 06/06/2016 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/2010 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Label for DURAMORPH | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018565s020ltr.pdf |
| 06/06/2005 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
Label for DURAMORPH | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018565s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018565s014ltr.pdf |
| 05/27/2004 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
Label for INFUMORPH | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/018565s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18565slr012ltr.pdf |
| 06/26/2003 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18565slr010ltr.pdf |
| 12/07/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/14/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1998 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/12/1997 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/03/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/19/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/19/1991 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/22/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/018565s036lbl.pdf | |
| 12/22/2025 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/018565s035lbl.pdf | |
| 12/15/2023 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s027,s031lbl.pdf | |
| 12/15/2023 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s028s030lbl.pdf | |
| 12/15/2023 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s028s030lbl.pdf | |
| 12/15/2023 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s027,s031lbl.pdf | |
| 11/08/2023 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565Orig1s029lbl.pdf | |
| 10/07/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018565s024lbl.pdf | |
| 12/16/2016 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | DURAMORPH & INFUMORPH have separate letters and labels | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Duramorph.pdf |
| 12/16/2016 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | DURAMORPH & INFUMORPH have separate letters and labels | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Duramorph.pdf |
| 12/16/2016 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | DURAMORPH & INFUMORPH have separate letters and labels | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Infumorph.pdf |
| 12/16/2016 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | DURAMORPH & INFUMORPH have separate letters and labels | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Infumorph.pdf |
| 10/01/2010 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | Label for DURAMORPH | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf |
| 06/06/2005 | SUPPL-14 | Labeling | Label (PDF) | Label for DURAMORPH | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018565s014lbl.pdf |
| 05/27/2004 | SUPPL-12 | Labeling | Label (PDF) | Label for INFUMORPH | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/018565s012lbl.pdf |
DURAMORPH PF
INJECTABLE;INJECTION; 0.5MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DURAMORPH PF | MORPHINE SULFATE | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018565 | HIKMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 073509 | HOSPIRA |
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DURAMORPH PF | MORPHINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018565 | HIKMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 073510 | HOSPIRA |
INFUMORPH
INJECTABLE;INJECTION; 10MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INFUMORPH | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018565 | HIKMA |
| MITIGO | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204393 | PIRAMAL CRITICAL |
| MORPHINE SULFATE | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205758 | HIKMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211452 | HIKMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 202515 | HOSPIRA INC |
INJECTABLE;INJECTION; 25MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INFUMORPH | MORPHINE SULFATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018565 | HIKMA |
| MITIGO | MORPHINE SULFATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204393 | PIRAMAL CRITICAL |