Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078717
Company: TEVA PHARMS
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
11/26/2008 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/078717s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078717s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/26/2018 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

10/26/2015 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

07/17/2012 SUPPL-11 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

01/31/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/26/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/078717s000lbl.pdf

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 AUROBINDO PHARMA LTD
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 091458 SAGENT PHARMS
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 078717 TEVA PHARMS
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 AUROBINDO PHARMA LTD
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 091458 SAGENT PHARMS
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 078717 TEVA PHARMS
ROCURONIUM BROMIDE ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 204679 WEST WARD PHARM CORP

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