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Last Updated: August 12, 2020

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Details for New Drug Application (NDA): 062365

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NDA 062365 describes CHLORAMPHENICOL SODIUM SUCCINATE, which is a drug marketed by Fresenius Kabi Usa and Gruppo Lepetit and is included in two NDAs. It is available from one supplier. Additional details are available on the CHLORAMPHENICOL SODIUM SUCCINATE profile page.

The generic ingredient in CHLORAMPHENICOL SODIUM SUCCINATE is chloramphenicol sodium succinate. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chloramphenicol sodium succinate profile page.
Summary for 062365
Tradename:CHLORAMPHENICOL SODIUM SUCCINATE
Applicant:Fresenius Kabi Usa
Ingredient:chloramphenicol sodium succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062365
Suppliers and Packaging for NDA: 062365
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORAMPHENICOL SODIUM SUCCINATE chloramphenicol sodium succinate INJECTABLE;INJECTION 062365 ANDA Fresenius Kabi USA, LLC 63323-011 63323-011-15 10 VIAL in 1 TRAY (63323-011-15) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Aug 25, 1982TE:RLD:No

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Serving leading biopharmaceutical companies globally:

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Baxter

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