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Last Updated: March 1, 2021

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Ampicillin sodium - Generic Drug Details

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What are the generic drug sources for ampicillin sodium and what is the scope of patent protection?

Ampicillin sodium is the generic ingredient in seven branded drugs marketed by Acs Dobfar Spa, Antibiotice, Apothecon, Aurobindo Pharma, Consolidated Pharm, Hanford Gc, Hospira Inc, Intl Medication, Istituto Bio Ita Spa, Lilly, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, Watson Labs Inc, West-ward Pharms Int, Wyeth Ayerst, Bristol, Glaxosmithkline, Acs Dobfar, Astral, Pharm Assoc, and Pfizer, and is included in fifty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy drug master file entries for ampicillin sodium. Fourteen suppliers are listed for this compound.

Summary for ampicillin sodium
US Patents:0
Tradenames:7
Applicants:22
NDAs:56
Drug Master File Entries: 70
Suppliers / Packagers: 14
Bulk Api Vendors: 58
Clinical Trials: 8
Patent Applications: 1,344
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in ampicillin sodium?ampicillin sodium excipients list
DailyMed Link:ampicillin sodium at DailyMed
Recent Clinical Trials for ampicillin sodium

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

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
DongGuk UniversityN/A
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all ampicillin sodium clinical trials

Pharmacology for ampicillin sodium
Medical Subject Heading (MeSH) Categories for ampicillin sodium

US Patents and Regulatory Information for ampicillin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol POLYCILLIN-N ampicillin sodium INJECTABLE;INJECTION 050309-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 065499-002 Aug 17, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
Istituto Bio Ita Spa AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065314-001 Nov 27, 2006 AP RX No No   Start Trial   Start Trial   Start Trial
Hanford Gc AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 062772-004 Apr 15, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Hanford Gc AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 062772-007 Apr 15, 1993 AP RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 065499-001 Aug 17, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Pharm Assoc AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065316-002 Jun 29, 2007 DISCN 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
AstraZeneca
Express Scripts
Boehringer Ingelheim
McKesson

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