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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
Sponsor | Phase |
---|---|
Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
DongGuk University | N/A |
Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Pharmacology for ampicillin sodium
Drug Class | Penicillin-class Antibacterial |
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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