BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Merck
Federal Trade Commission
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Accenture
Citi
Julphar
US Department of Justice
Teva
Chinese Patent Office
Moodys

Generated: January 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065453

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NDA 065453 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-four 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 065453
Tradename:VANCOMYCIN HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:vancomycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065453
Ingredient-typeGlycopeptides
Medical Subject Heading (MeSH) Categories for 065453
Suppliers and Packaging for NDA: 065453
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride CAPSULE;ORAL 065453 ANDA Fresenius Kabi USA, LLC 63323-338 63323-338-22 2 BLISTER PACK in 1 CARTON (63323-338-22) > 10 CAPSULE in 1 BLISTER PACK
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride CAPSULE;ORAL 065453 ANDA Fresenius Kabi USA, LLC 63323-338 63323-338-20 2 BLISTER PACK in 1 CARTON (63323-338-20) > 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 125MG BASE
Approval Date:Jun 18, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Jun 18, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Julphar
Harvard Business School
Novartis
US Army
UBS
Daiichi Sankyo
Express Scripts
Covington
Merck

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