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Generated: May 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203702

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NDA 203702 describes CEFTRIAXONE, which is a drug marketed by Acs Dobfar, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu Pharm Co Ltd, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt, Akorn Inc, Astral, Cephazone Pharma, Hikma Farmaceutica, Teva Pharms Usa, B Braun, and Baxter Hlthcare, and is included in thirty-six NDAs. It is available from twenty-four suppliers. Additional details are available on the CEFTRIAXONE profile page.

The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
Summary for 203702
Tradename:CEFTRIAXONE
Applicant:Qilu Pharm Co Ltd
Ingredient:ceftriaxone sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203702
Medical Subject Heading (MeSH) Categories for 203702
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 A-S Medication Solutions 50090-3810 50090-3810-1 10 VIAL, SINGLE-USE in 1 CARTON (50090-3810-1) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 203702 ANDA A-S Medication Solutions 50090-3838 50090-3838-0 1 VIAL, SINGLE-USE in 1 CARTON (50090-3838-0) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE

Profile for product number 001

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

Profile for product number 002

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

Profile 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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