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Last Updated: May 27, 2024

Details for New Drug Application (NDA): 014134

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NDA 014134 describes PROTOPAM CHLORIDE, which is a drug marketed by Baxter Hlthcare Corp and Wyeth Ayerst and is included in two NDAs. It is available from two suppliers. Additional details are available on the PROTOPAM CHLORIDE profile page.

The generic ingredient in PROTOPAM CHLORIDE is pralidoxime chloride. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pralidoxime chloride profile page.
Summary for 014134
Applicant:Baxter Hlthcare Corp
Ingredient:pralidoxime chloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 014134
Mechanism of ActionCholinesterase Reactivators
Suppliers and Packaging for NDA: 014134
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROTOPAM CHLORIDE pralidoxime chloride INJECTABLE;INJECTION 014134 NDA Baxter Healthcare Corporation 60977-141 60977-141-01 6 VIAL, SINGLE-DOSE in 1 PACKAGE (60977-141-01) / 20 mL in 1 VIAL, SINGLE-DOSE (60977-141-27)
PROTOPAM CHLORIDE pralidoxime chloride INJECTABLE;INJECTION 014134 NDA Bamboo US BidCo LLC 83703-036 83703-036-01 6 VIAL, SINGLE-DOSE in 1 PACKAGE (83703-036-01) / 20 mL in 1 VIAL, SINGLE-DOSE (83703-036-27)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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