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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072320
Company: HOSPIRA

Products on ANDA 072320

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072320

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-Container/Carton Labels, Labeling-Package Insert		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.

Therapeutic Equivalents for ANDA 072320

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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