Drugs@FDA: FDA-Approved Drugs

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

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

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-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
02/05/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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 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 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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