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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090579

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NDA 090579 describes AMPICILLIN AND SULBACTAM, which is a drug marketed by Acs Dobfar, Antibiotice, Sandoz, Istituto Bio Ita Spa, Mustafa Nevzat Ilac, Mylan Labs Ltd, Aurobindo Pharma, Hospira Inc, West-ward Pharms Int, Hanford Gc, and Sagent Pharms, and is included in twenty-three NDAs. It is available from twelve suppliers. Additional details are available on the AMPICILLIN AND SULBACTAM profile page.

The generic ingredient in AMPICILLIN AND SULBACTAM is ampicillin sodium; sulbactam sodium. There are sixty-nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.

Summary for NDA: 090579

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

Pharmacology for NDA: 090579

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 090579

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN AND SULBACTAM
ampicillin sodium; sulbactam sodium
INJECTABLE;INJECTION 090579 ANDA Sagent Pharmaceuticals 25021-186 25021-186-20 10 VIAL in 1 CARTON (25021-186-20) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
AMPICILLIN AND SULBACTAM
ampicillin sodium; sulbactam sodium
INJECTABLE;INJECTION 090579 ANDA Sagent Pharmaceuticals 25021-187 25021-187-30 10 VIAL in 1 CARTON (25021-187-30) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Jan 8, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date:Jan 8, 2016TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
QuintilesIMS
Healthtrust
US Army
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Cerilliant
Fish and Richardson
McKinsey
Merck

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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