Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072320
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PANCURONIUM BROMIDE PANCURONIUM BROMIDE 1MG/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
01/19/1989 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
07/26/2018 SUPPL-28 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/22/2010 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

04/15/2009 SUPPL-18 Labeling

Label is not available on this site.

09/07/2004 SUPPL-13 Labeling

Label is not available on this site.

07/08/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/08/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/08/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/22/1996 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/27/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/11/1995 SUPPL-4 Labeling

Label is not available on this site.

08/11/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/11/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/15/1989 SUPPL-1 Labeling

Label is not available on this site.

PANCURONIUM BROMIDE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PANCURONIUM BROMIDE PANCURONIUM BROMIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 072759 DR REDDYS
PANCURONIUM BROMIDE PANCURONIUM BROMIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 072320 HOSPIRA

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