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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050309

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NDA 050309 describes POLYCILLIN-N, which is a drug marketed by Bristol and is included in one NDA. Additional details are available on the POLYCILLIN-N profile page.

The generic ingredient in POLYCILLIN-N is ampicillin sodium. There are sixty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.

Summary for 050309

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

Medical Subject Heading (MeSH) Categories for 050309

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Dow
Federal Trade Commission
US Army
Harvard Business School
Cipla
Boehringer Ingelheim
Johnson and Johnson
Cerilliant
AstraZeneca
Queensland Health

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