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Generated: May 26, 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-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 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 A-S Medication Solutions 50090-0945 50090-0945-0 10 VIAL in 1 CARTON (50090-0945-0) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065125 ANDA A-S Medication Solutions 50090-1773 50090-1773-0 10 INJECTION, POWDER, FOR SOLUTION in 1 BOX (50090-1773-0)

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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