Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019101
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.025MG BASE/0.5ML | INJECTABLE;INJECTION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 07/11/1984 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/03/2023 | SUPPL-61 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 01/20/2023 | SUPPL-60 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019101Orig1s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019101Orig1s060ltr.pdf | |
| 10/08/2019 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019101s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019101Orig1s051ltr.pdf | |
| 01/24/2019 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019101s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019101Orig1s047ltr.pdf | |
| 12/16/2016 | SUPPL-45 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019101s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019101Orig1s045ltr.pdf | |
| 05/26/2016 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2016 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/2015 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/2014 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/2014 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/2013 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 02/13/2012 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 02/25/2010 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 08/28/2001 | SUPPL-20 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/29/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1994 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/01/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/16/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/19/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1985 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 01/20/2023 | SUPPL-60 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019101Orig1s060lbl.pdf | |
| 10/08/2019 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019101s051lbl.pdf | |
| 01/24/2019 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019101s047lbl.pdf | |
| 12/16/2016 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019101s045lbl.pdf | |
| 12/16/2016 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019101s045lbl.pdf |
FENTANYL CITRATE
INJECTABLE;INJECTION; EQ 0.05MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212086 | FRESENIUS KABI USA |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019101 | HIKMA |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 019115 | HOSPIRA |
| FENTANYL CITRATE PRESERVATIVE FREE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210762 | FRESENIUS KABI USA |
| FENTANYL CITRATE PRESERVATIVE FREE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072786 | HOSPIRA |
| SUBLIMAZE PRESERVATIVE FREE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016619 | AKORN |