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Details for New Drug Application (NDA): 065314

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NDA 065314 describes AMPICILLIN AND SULBACTAM, which is a drug marketed by Acs Dobfar, Antibiotics Sa, Sandoz, Istituto Bio Ita Spa, Mustafa Nevzat Ilac, Mylan Labs Ltd, Aurobindo Pharma, Hospira Inc, Eurohlth Intl Sarl, Hanford Gc, and Sagent Pharms, and is included in twenty-three NDAs. It is available from thirteen 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-eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.

Summary for NDA: 065314

Istituto Bio Ita Spa
ampicillin sodium; sulbactam sodium
Therapeutic Class:Antibacterials

Pharmacology for NDA: 065314

Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 065314

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ampicillin sodium; sulbactam sodium
INJECTABLE;INJECTION 065314 ANDA APP Pharmaceuticals, LLC 63323-370 63323-370-62 10 VIAL in 1 CARTON (63323-370-62) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Summary for product number 001

Approval Date:Nov 27, 2006TE:APRLD:No

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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.