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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 207322


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NDA 207322 describes POLYMYXIN B SULFATE, which is a drug marketed by Adrastea Pharma, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Rising, Xellia Pharms Aps, and Paddock Llc, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the POLYMYXIN B SULFATE profile page.

The generic ingredient in POLYMYXIN B SULFATE is polymyxin b sulfate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.
Summary for 207322
Tradename:POLYMYXIN B SULFATE
Applicant:Gland
Ingredient:polymyxin b sulfate
Patents:0
Pharmacology for NDA: 207322
Medical Subject Heading (MeSH) Categories for 207322
Suppliers and Packaging for NDA: 207322
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 207322 ANDA Gland Pharma Limited 68083-174 68083-174-10 10 VIAL in 1 CARTON (68083-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (68083-174-01)
POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 207322 ANDA Athenex Pharmaceutical Division, LLC. 70860-103 70860-103-10 10 VIAL in 1 CARTON (70860-103-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70860-103-41)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500,000 UNITS BASE/VIAL
Approval Date:Apr 14, 2016TE:APRLD:No

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