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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065124

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NDA 065124 describes CEFOTAXIME SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Aurobindo Pharma, Lupin, Hospira Inc, Cephazone Pharma, and Wockhardt, and is included in nine NDAs. It is available from three suppliers. Additional details are available on the CEFOTAXIME SODIUM profile page.

The generic ingredient in CEFOTAXIME SODIUM is cefotaxime sodium. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cefotaxime sodium profile page.

Summary for NDA: 065124

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

Pharmacology for NDA: 065124

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065124

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFOTAXIME SODIUM
cefotaxime sodium
INJECTABLE;INJECTION 065124 ANDA Lupin Pharmaceuticals, Inc. 68180-811 68180-811-10 10 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (68180-811-10)
CEFOTAXIME SODIUM
cefotaxime sodium
INJECTABLE;INJECTION 065124 ANDA Lupin Pharmaceuticals, Inc. 68180-822 68180-822-10 10 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (68180-822-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Sep 24, 2003TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Sep 24, 2003TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Sep 24, 2003TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Teva
Cantor Fitzgerald
Colorcon
Covington
Mallinckrodt
Healthtrust
Deloitte
Express Scripts
Queensland Health
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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