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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203725
Company: HIKMA

Products on ANDA 203725

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	No
VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203725

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2019	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
12/09/2025	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203725

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

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