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Serving hundreds of leading biopharmaceutical companies globally:

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201404

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NDA 201404 describes AMPICILLIN SODIUM, which is a drug marketed by Acs Dobfar Spa, Antibiotice, Apothecon, Aurobindo Pharma, Consolidated Pharm, Hanford Gc, Hospira Inc, Intl Medication, Istituto Bio Ita Spa, Lilly, Mylan Labs Ltd, Sagent Pharms, Sandoz, Watson Labs Inc, and West-ward Pharms Int, and is included in twenty-five NDAs. It is available from seventeen suppliers. Additional details are available on the AMPICILLIN SODIUM profile page.

The generic ingredient in AMPICILLIN SODIUM 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 201404

Tradename:	AMPICILLIN SODIUM
Applicant:	Istituto Bio Ita Spa
Ingredient:	ampicillin sodium
Patents:	0
Therapeutic Class:	Antibacterials
Formulation / Manufacturing:	see details

Pharmacology for NDA: 201404

Ingredient-type	Penicillins

Medical Subject Heading (MeSH) Categories for 201404

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 201404

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMPICILLIN SODIUM	ampicillin sodium	INJECTABLE;INJECTION	201404	ANDA	APP Pharmaceuticals, LLC	63323-404	E	63323-404-00
AMPICILLIN SODIUM	ampicillin sodium	INJECTABLE;INJECTION	201404	ANDA	Athenex Pharmaceutical Division, LLC.	70860-118	N	70860-118-99

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	Dec 20, 2013	TE:	AP	RLD:	No

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