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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205656
Company: GLAND PHARMA LTD

Products on ANDA 205656

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205656

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/04/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2020	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
02/05/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205656

ROCURONIUM BROMIDE

INJECTABLE;INJECTION; 50MG/5ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	206206	EUGIA PHARMA
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078651	FRESENIUS KABI USA
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	205656	GLAND PHARMA LTD
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078519	HOSPIRA
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	079199	MYLAN INSTITUTIONAL
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210437	PIRAMAL CRITICAL
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	212668	PRINSTON INC
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091458	SAGENT PHARMS INC
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	079195	SANDOZ INC
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091115	TAMARANG
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	204679	WEST WARD PHARM CORP

INJECTABLE;INJECTION; 100MG/10ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	206206	EUGIA PHARMA
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078651	FRESENIUS KABI USA
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	205656	GLAND PHARMA LTD
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078519	HOSPIRA
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	079199	MYLAN INSTITUTIONAL
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210437	PIRAMAL CRITICAL
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	212668	PRINSTON INC
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091458	SAGENT PHARMS INC
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	079195	SANDOZ INC
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091115	TAMARANG
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	204679	WEST WARD PHARM CORP

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