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Generated: November 21, 2018

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Details for New Drug Application (NDA): 065328

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NDA 065328 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 065328
Tradename:CEFTRIAXONE
Applicant:Acs Dobfar
Ingredient:ceftriaxone sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065328
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065328
Suppliers and Packaging for NDA: 065328
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INJECTION 065328 ANDA West-Ward Pharmaceutical Corp 0143-9768 0143-9768-46 1 VIAL in 1 BOX (0143-9768-46) > 100 mL in 1 VIAL (0143-9768-01)
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INJECTION 065328 ANDA Sagent Pharmaceuticals 25021-108 25021-108-99 1 BOTTLE in 1 CARTON (25021-108-99) > 100 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Jul 24, 2008TE:APRLD:No

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