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Generated: November 22, 2018

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Details for New Drug Application (NDA): 062373

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NDA 062373 describes GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, and Hospira, and is included in four NDAs. It is available from one supplier. Additional details are available on the GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 062373
Tradename:GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Baxter Hlthcare
Ingredient:gentamicin sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062373
Ingredient-typeAminoglycosides
Suppliers and Packaging for NDA: 062373
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER gentamicin sulfate INJECTABLE;INJECTION 062373 ANDA Baxter Healthcare Corporation 0338-0503 0338-0503-48 100 mL in 1 BAG (0338-0503-48)
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER gentamicin sulfate INJECTABLE;INJECTION 062373 ANDA Baxter Healthcare Corporation 0338-0505 0338-0505-48 100 mL in 1 BAG (0338-0505-48)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 0.8MG BASE/ML
Approval Date:Sep 7, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 80MG BASE/100ML
Approval Date:Sep 7, 1982TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/100ML
Approval Date:Sep 7, 1982TE:RLD:No

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