Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072786
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE PRESERVATIVE FREE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 09/24/1991 | 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 |
|---|---|---|---|---|---|
| 07/15/2024 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/22/2024 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/19/2024 | SUPPL-40 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 06/11/2020 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/11/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/11/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/14/2001 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/22/1995 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/16/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |