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Generated: November 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065342

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NDA 065342 describes CEFTRIAXONE, which is a drug marketed by Acs Dobfar, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt, Akorn Inc, Cephazone Pharma, Hikma Farmaceutica, Qilu Pharm Co Ltd, Sagent Pharms, Teva Pharms Usa, B Braun, and Baxter Hlthcare, and is included in thirty-five 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 065342
Tradename:CEFTRIAXONE
Applicant:Hikma Farmaceutica
Ingredient:ceftriaxone sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065342
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065342
Suppliers and Packaging for NDA: 065342
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065342 ANDA West-Ward Pharmaceuticals Corp 0143-9856 0143-9856-25 25 VIAL in 1 BOX (0143-9856-25) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9856-01)
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065342 ANDA West-Ward Pharmaceuticals Corp 0143-9857 0143-9857-25 25 VIAL in 1 BOX (0143-9857-25) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9857-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 250MG BASE/VIAL
Approval Date:Jan 10, 2008TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 500MG BASE/VIAL
Approval Date:Jan 10, 2008TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 1GM BASE/VIAL
Approval Date:Jan 10, 2008TE:APRLD:No

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