Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071982
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE AND DROPERIDOL | DROPERIDOL; FENTANYL CITRATE | 2.5MG/ML;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 |
|---|---|---|---|---|---|---|---|
| 05/04/1988 | 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 |
|---|---|---|---|---|---|
| 10/03/1996 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 01/24/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 12/02/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/07/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 10/04/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |