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Serving leading biopharmaceutical companies globally:

McKinsey
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Farmers Insurance
Fuji
AstraZeneca
Julphar
Federal Trade Commission
Chinese Patent Office
QuintilesIMS
Queensland Health

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065490

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NDA 065490 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 065490

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065490

Ingredient-typeGlycopeptides

Medical Subject Heading (MeSH) Categories for 065490

Suppliers and Packaging for NDA: 065490

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride CAPSULE;ORAL 065490 ANDA Alvogen, Inc. 47781-729 47781-729-01 100 CAPSULE in 1 BOTTLE (47781-729-01)
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride CAPSULE;ORAL 065490 ANDA Alvogen, Inc. 47781-729 47781-729-50 50 CAPSULE in 1 BOTTLE (47781-729-50)

Summary for product number 001

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

Summary 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 leading biopharmaceutical companies globally:

Julphar
Accenture
Merck
UBS
Farmers Insurance
Johnson and Johnson
Deloitte
Cerilliant
Federal Trade Commission
Daiichi Sankyo

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