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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Johnson and Johnson
Chinese Patent Office
Cantor Fitzgerald

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065478

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NDA 065478 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Akorn, Fresenius Kabi Usa, Lupin Ltd, Strides Pharma, Watson Labs, Aurobindo Pharma Ltd, Cft Pharms Llc, Emcure Pharms Ltd, Gland Pharma Ltd, Hospira, Hospira Inc, Mustafa Nevzat Ilac, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sandoz Inc, Teva Pharms Usa, West-ward Pharms Int, Xellia Pharms Aps, and Samson Medcl, and is included in thirty-four NDAs. It is available from twenty-three suppliers. Additional details are available on the VANCOMYCIN HYDROCHLORIDE profile page.

The generic ingredient in VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 065478
Ingredient:vancomycin hydrochloride
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065478
Medical Subject Heading (MeSH) Categories for 065478
Suppliers and Packaging for NDA: 065478
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride CAPSULE;ORAL 065478 ANDA Akorn, Inc. 17478-741 N 17478-741-02
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride CAPSULE;ORAL 065478 ANDA Akorn, Inc. 17478-742 N 17478-742-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 125MG BASE
Approval Date:Apr 9, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Apr 9, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School

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