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Last Updated: December 12, 2019

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Ampicillin sodium; sulbactam sodium - Generic Drug Details

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What are the generic drug sources for ampicillin sodium; sulbactam sodium and what is the scope of freedom to operate?

Ampicillin sodium; sulbactam sodium is the generic ingredient in two branded drugs marketed by Acs Dobfar, Antibiotice, Astral, Aurobindo Pharma, Hanford Gc, Hospira Inc, Istituto Bio Ita Spa, Mustafa Nevzat Ilac, Mylan Labs Ltd, Sandoz, West-ward Pharms Int, and Pfizer, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy drug master file entries for ampicillin sodium; sulbactam sodium. Twelve suppliers are listed for this compound.

Summary for ampicillin sodium; sulbactam sodium
Recent Clinical Trials for ampicillin sodium; sulbactam sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
DongGuk UniversityN/A
PfizerPhase 3

See all ampicillin sodium; sulbactam sodium clinical trials

Pharmacology for ampicillin sodium; sulbactam sodium

US Patents and Regulatory Information for ampicillin sodium; sulbactam sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astral AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 090579-001 Jan 8, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Istituto Bio Ita Spa AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065222-002 Nov 29, 2005 AP RX No No   Start Trial   Start Trial   Start Trial
Sandoz AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065240-001 Jul 25, 2006 AP RX No No   Start Trial   Start Trial   Start Trial
Acs Dobfar AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065406-002 Dec 22, 2009 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 201024-002 Apr 7, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 090340-001 Sep 20, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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