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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075549
Company: HIKMA

Products on ANDA 075549

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 075549

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75549ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2018	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/075549s013lbl.pdf
11/23/2010	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/075549s009lbl.pdf
03/01/2007	SUPPL-7	Labeling		Label is not available on this site.
02/26/2001	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 075549

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/075549s013lbl.pdf
07/26/2018	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/075549s013lbl.pdf
11/23/2010	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/075549s009lbl.pdf

Therapeutic Equivalents for ANDA 075549

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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