Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071981
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DROPERIDOL DROPERIDOL 2.5MG/ML INJECTABLE;INJECTION Prescription AP 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
02/29/1988 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
01/24/2002 SUPPL-9 Labeling

Label is not available on this site.

10/03/1996 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

01/30/1996 SUPPL-5 Labeling

Label is not available on this site.

06/28/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/11/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/20/1989 SUPPL-2 Labeling

Label is not available on this site.

06/12/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DROPERIDOL

INJECTABLE;INJECTION; 2.5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DROPERIDOL DROPERIDOL 2.5MG/ML INJECTABLE;INJECTION Prescription No AP 208197 EUROHLTH INTL SARL
DROPERIDOL DROPERIDOL 2.5MG/ML INJECTABLE;INJECTION Prescription No AP 071981 HOSPIRA
DROPERIDOL DROPERIDOL 2.5MG/ML INJECTABLE;INJECTION Prescription No AP 072123 LUITPOLD
INAPSINE DROPERIDOL 2.5MG/ML INJECTABLE;INJECTION Prescription Yes AP 016796 AKORN INC

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