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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 063142


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NDA 063142 describes AMPICILLIN SODIUM, which is a drug marketed by Acs Dobfar Spa, Antibiotice, Apothecon, Consolidated Pharm, Eugia Pharma Speclts, Hikma, Hospira, Hq Speclt Pharma, Intl Medication, Istituto Bio Ita Spa, Lilly, Sagent Pharms Inc, Sandoz, Steriscience, and Watson Labs Inc, and is included in twenty-five NDAs. It is available from eighteen suppliers. Additional details are available on the AMPICILLIN SODIUM profile page.

The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There are seventy drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
Summary for 063142
Tradename:AMPICILLIN SODIUM
Applicant:Hq Speclt Pharma
Ingredient:ampicillin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 063142
Medical Subject Heading (MeSH) Categories for 063142
Suppliers and Packaging for NDA: 063142
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 063142 ANDA WG Critical Care, LLC 44567-104 44567-104-01 1 VIAL in 1 CARTON (44567-104-01) / 100 mL in 1 VIAL
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 063142 ANDA WG Critical Care, LLC 44567-104 44567-104-10 10 VIAL in 1 TRAY (44567-104-10) / 100 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Apr 15, 1993TE:APRLD:No

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