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Generated: December 10, 2018

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Details for New Drug Application (NDA): 206831

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NDA 206831 describes ISOSULFAN BLUE, which is a drug marketed by Aurobindo Pharma Ltd and Mylan Institutional and is included in two NDAs. It is available from two suppliers. Additional details are available on the ISOSULFAN BLUE profile page.

The generic ingredient in ISOSULFAN BLUE is isosulfan blue. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the isosulfan blue profile page.
Summary for 206831
Tradename:ISOSULFAN BLUE
Applicant:Aurobindo Pharma Ltd
Ingredient:isosulfan blue
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206831
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSULFAN BLUE isosulfan blue INJECTABLE;INJECTION 206831 ANDA AuroMedics Pharma LLC 55150-240 55150-240-06 6 VIAL in 1 CARTON (55150-240-06) > 5 mL in 1 VIAL
ISOSULFAN BLUE isosulfan blue INJECTABLE;INJECTION 206831 ANDA AuroMedics Pharma LLC 55150-240 55150-240-05 6 VIAL in 1 CARTON (55150-240-05) > 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1%
Approval Date:Feb 2, 2016TE:APRLD:No

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