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Generated: November 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065391

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NDA 065391 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 065391
Tradename:CEFTRIAXONE
Applicant:Wockhardt
Ingredient:ceftriaxone sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065391
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065391
Suppliers and Packaging for NDA: 065391
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065391 ANDA Rebel Distributors Corp 42254-152 42254-152-10 1 INJECTION, POWDER, FOR SOLUTION in 1 BOX (42254-152-10)
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065391 ANDA Rebel Distributors Corp 42254-191 42254-191-01 1 INJECTION, POWDER, FOR SOLUTION in 1 BOX (42254-191-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 250MG BASE/VIAL
Approval Date:Apr 12, 2007TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 500MG BASE/VIAL
Approval Date:Apr 12, 2007TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 2GM BASE/VIAL
Approval Date:Apr 12, 2007TE:APRLD:No

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