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 206831 EUGIA PHARMA
ISOSULFAN BLUE ISOSULFAN BLUE 1% INJECTABLE;INJECTION Prescription No AP 213130 HONG KONG
ISOSULFAN BLUE ISOSULFAN BLUE 1% INJECTABLE;INJECTION Prescription No AP 090874 MYLAN INSTITUTIONAL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English