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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203702

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NDA 203702 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, Baxter Hlthcare, and Sagent Pharms, and is included in thirty-three 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: 203702

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 203702

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 203702

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE
ceftriaxone sodium
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 203702 ANDA Apotex Corp. 60505-6148 60505-6148-4 10 VIAL, SINGLE-USE in 1 CARTON (60505-6148-4) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (60505-6148-0)
CEFTRIAXONE
ceftriaxone sodium
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 203702 ANDA Apotex Corp. 60505-6149 60505-6149-4 10 VIAL, SINGLE-USE in 1 CARTON (60505-6149-4) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (60505-6149-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 250MG BASE/VIAL
Approval Date:Jun 29, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 29, 2016TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 1GM BASE/VIAL
Approval Date:Jun 29, 2016TE:APRLD:No


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