U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090874
Company: MYLAN INSTITUTIONAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSULFAN BLUE ISOSULFAN BLUE 1% INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/20/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090874s000ltr.pdf

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 211869 FRESENIUS KABI USA
ISOSULFAN BLUE ISOSULFAN BLUE 1% INJECTABLE;INJECTION Prescription No AP 213130 MEITHEAL
ISOSULFAN BLUE ISOSULFAN BLUE 1% INJECTABLE;INJECTION Prescription No AP 216090 MSN
ISOSULFAN BLUE ISOSULFAN BLUE 1% INJECTABLE;INJECTION Prescription No AP 090874 MYLAN INSTITUTIONAL
Back to Top