Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210558
Company: SOMERSET THERAPS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSULFAN BLUE ISOSULFAN BLUE 1% 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
07/12/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

ISOSULFAN BLUE

INJECTABLE;INJECTION; 1%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOSULFAN BLUE ISOSULFAN BLUE 1% INJECTABLE;INJECTION Prescription No AP 206831 AUROBINDO PHARMA LTD
ISOSULFAN BLUE ISOSULFAN BLUE 1% INJECTABLE;INJECTION Prescription No AP 090874 MYLAN INSTITUTIONAL
ISOSULFAN BLUE ISOSULFAN BLUE 1% INJECTABLE;INJECTION Prescription No AP 210558 SOMERSET THERAPS LLC

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