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Details for New Drug Application (NDA): 065125

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NDA 065125 describes CEFTRIAXONE, which is a drug marketed by Qilu Pharm Co Ltd, Aurobindo Pharma Ltd, Sandoz Inc, Akorn Inc, Lupin, Teva Pharms Usa, Acs Dobfar, Hospira Inc, Hikma Farmaceutica, Fresenius Kabi Usa, Samson Medcl, Teva, Bedford, Agila Speclts, Sandoz, Facta Farma, Wockhardt, Cephazone Pharma, B Braun, and Baxter Hlthcare, and is included in thirty-two NDAs. It is available from twenty-five suppliers. Additional details are available on the CEFTRIAXONE profile page.

The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There are twenty-three drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.

Summary for NDA: 065125

Tradename:
CEFTRIAXONE
Applicant:
Lupin
Ingredient:
ceftriaxone sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065125

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065125

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE
ceftriaxone sodium
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065125 ANDA BAXTER HEALTHCARE CORPORATION 10019-098 10019-098-01 10 VIAL in 1 BOX (10019-098-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (10019-098-71)
CEFTRIAXONE
ceftriaxone sodium
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065125 ANDA A-S Medication Solutions 50090-0945 50090-0945-0 10 INJECTION, POWDER, FOR SOLUTION in 1 BOX (50090-0945-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 250MG BASE/VIAL
Approval Date:Sep 30, 2003TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 500MG BASE/VIAL
Approval Date:Sep 30, 2003TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 1GM BASE/VIAL
Approval Date:Sep 30, 2003TE:APRLD:No


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