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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 065403


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NDA 065403 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 thirteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
Summary for 065403
Pharmacology for NDA: 065403
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065403
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065403 ANDA Hikma Pharmaceuticals USA Inc. 0641-6118 0641-6118-01 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01)
AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065403 ANDA West-Ward Pharmaceuticals Corp. 0641-6121 0641-6121-01 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6121-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Approval Date:Dec 23, 2009TE:APRLD:No

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