Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 072759
Company: DR REDDYS

Products on ANDA 072759

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072759

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/1990	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-26	Labeling-Package Insert		Label is not available on this site.
05/10/2012	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
11/22/2010	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/24/2009	SUPPL-8	Labeling		Label is not available on this site.
03/29/2004	SUPPL-4	Labeling		Label is not available on this site.
04/18/1994	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/14/1992	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 072759

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