Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071982
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.

01/24/1995 SUPPL-4 Labeling

Label is not available on this site.

12/02/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/07/1990 SUPPL-2 Labeling

Label is not available on this site.

10/04/1989 SUPPL-1 Labeling

Label is not available on this site.

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