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Last Updated: November 10, 2024

Details for New Drug Application (NDA): 062719


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NDA 062719 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 Speclts, and Watson Labs Inc, and is included in twenty-five NDAs. It is available from sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
Summary for 062719
Tradename:AMPICILLIN SODIUM
Applicant:Istituto Bio Ita Spa
Ingredient:ampicillin sodium
Patents:0
Pharmacology for NDA: 062719
Medical Subject Heading (MeSH) Categories for 062719
Suppliers and Packaging for NDA: 062719
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 062719 ANDA Henry Schein, Inc. 0404-9803 0404-9803-99 1 VIAL in 1 BAG (0404-9803-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 062719 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1595 51662-1595-3 10 POUCH in 1 CASE (51662-1595-3) / 1 VIAL in 1 POUCH (51662-1595-2) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:May 12, 1987TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:May 12, 1987TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:May 12, 1987TE:APRLD:No

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