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Last Updated: October 16, 2024

Details for New Drug Application (NDA): 090578


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NDA 090578 describes AMPICILLIN AND SULBACTAM, which is a drug marketed by Acs Dobfar, Antibiotice, Astral, Eugia Pharma Speclts, Hikma, Hospira Inc, Hq Speclt Pharma, Istituto Bio Ita Spa, Pharm Assoc, Sandoz, and Steriscience, and is included in twenty-three NDAs. It is available from eleven 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 seventy drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
Summary for 090578
Tradename:AMPICILLIN AND SULBACTAM
Applicant:Astral
Ingredient:ampicillin sodium; sulbactam sodium
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date:Jan 11, 2016TE:RLD:No

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