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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 213130


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NDA 213130 describes ISOSULFAN BLUE, which is a drug marketed by Am Regent, Beloteca, Eugia Pharma, Fresenius Kabi Usa, Meitheal, MSN, Mylan Institutional, and Somerset Theraps Llc, and is included in eight NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the isosulfan blue profile page.
Summary for 213130
Tradename:ISOSULFAN BLUE
Applicant:Meitheal
Ingredient:isosulfan blue
Patents:0
Suppliers and Packaging for NDA: 213130
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSULFAN BLUE isosulfan blue SOLUTION;SUBCUTANEOUS 213130 ANDA Meitheal Pharmaceuticals Inc. 71288-805 71288-805-06 6 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength50MG/5ML (10MG/ML)
Approval Date:Nov 3, 2021TE:APRLD:No

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