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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079195
Company: SANDOZ

Products on ANDA 079195

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	Yes
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079195

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/05/2008	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
06/20/2023	SUPPL-22	Labeling-Container/Carton Labels		Label is not available on this site.
05/03/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/26/2018	SUPPL-16	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/16/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/12/2013	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/24/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079195

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	216234	CAPLIN
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	217034	HIKMA
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	213453	MEITHEAL
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
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	216234	CAPLIN
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	213453	MEITHEAL
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
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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