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Generated: January 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065125

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NDA 065125 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-five 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-six suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
Summary for 065125
Tradename:CEFTRIAXONE
Applicant:Lupin
Ingredient:ceftriaxone sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065125
Medical Subject Heading (MeSH) Categories for 065125
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 LUPIN LIMITED 57297-611 57297-611-01 1 INJECTION, POWDER, FOR SOLUTION in 1 BOX (57297-611-01)

Profile for product number 001

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

Profile for product number 002

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

Profile 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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