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Generated: November 20, 2018

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Details for New Drug Application (NDA): 090057

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NDA 090057 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 090057
Tradename:CEFTRIAXONE
Applicant:Samson Medcl
Ingredient:ceftriaxone sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090057
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 090057
Suppliers and Packaging for NDA: 090057
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INJECTION 090057 ANDA Samson Medical Technologies, LLC 66288-6100 66288-6100-1 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG (66288-6100-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100GM BASE/VIAL
Approval Date:Apr 25, 2014TE:RLD:No

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