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Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065391

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NDA 065391 describes CEFTRIAXONE, which is a drug marketed by Qilu Pharm Co Ltd, Aurobindo Pharma Ltd, Sandoz Inc, Akorn Inc, Lupin, Teva Pharms Usa, Acs Dobfar, Hospira Inc, Hikma Farmaceutica, Fresenius Kabi Usa, Samson Medcl, Teva, Bedford, Agila Speclts, Sandoz, Facta Farma, Wockhardt, Cephazone Pharma, B Braun, Baxter Hlthcare, and Sagent Pharms, and is included in thirty-four NDAs. It is available from twenty-eight suppliers. Additional details are available on the CEFTRIAXONE profile page.

The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There are twenty-four drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.

Summary for NDA: 065391

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065391

Ingredient-typeCephalosporins

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)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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