Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075221
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALFENTANIL | ALFENTANIL HYDROCHLORIDE | EQ 0.5MG 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 |
|---|---|---|---|---|---|---|---|
| 10/28/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75221ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/28/2024 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/26/2024 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2021 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2021 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/20/2002 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |