Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207426
Company: NAMIGEN LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/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
12/08/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207426Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207426Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/08/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207426Orig1s000lbl.pdf

SODIUM NITROPRUSSIDE

INJECTABLE;INJECTION; 25MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROPRESS SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 071961 HOSPIRA
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 208635 AKORN
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 209493 AMNEAL PHARMS CO
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 209832 AMPHASTAR PHARMS INC
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 210855 CIPLA
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 209584 MEDICURE
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 209352 MICRO LABS
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 210763 MYLAN LABS LTD
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 207426 NAMIGEN LLC
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 207499 NEXUS PHARMS
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 209834 RENAISSANCE SSA LLC
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 210882 SOMERSET THERAPS LLC
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 210467 SUN PHARM INDS LTD

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