An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 079001
Company: SUN PHARM

Products on ANDA 079001

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079001

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2009	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-17	Labeling-Package Insert		Label is not available on this site.
11/23/2010	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079001

VECURONIUM BROMIDE

INJECTABLE;INJECTION; 10MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206670	EUGIA PHARMA
VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205390	GLAND
VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075549	HIKMA
VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203725	HIKMA
VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075164	HOSPIRA
VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	074688	MEITHEAL
VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090243	MYLAN LABS LTD
VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078274	SAGENT PHARMS INC
VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	079001	SUN PHARM

INJECTABLE;INJECTION; 20MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206670	EUGIA PHARMA
VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205390	GLAND
VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075549	HIKMA
VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203725	HIKMA
VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075164	HOSPIRA
VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	074688	MEITHEAL
VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090243	MYLAN LABS LTD
VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	078274	SAGENT PHARMS INC
VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	079001	SUN PHARM

Top