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Serving 500+ biopharmaceutical companies globally:

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Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065455

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NDA 065455 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Co, Cft Pharms Llc, Watson Labs, Hospira, Mylan Labs Ltd, Sagent Pharms, Lupin Ltd, Xellia Pharms Aps, Sandoz Inc, Sandoz, Teva Pharms Usa, Fresenius Kabi Usa, Hospira Inc, Emcure Pharms Ltd, Akorn, Aurobindo Pharma Ltd, West-ward Pharms Int, Strides Pharma, Gland Pharma Ltd, and Samson Medcl, and is included in thirty-four NDAs. It is available from twenty-two suppliers. Additional details are available on the VANCOMYCIN HYDROCHLORIDE profile page.

The generic ingredient in VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There are twenty-one drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.

Summary for NDA: 065455

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

Pharmacology for NDA: 065455

Ingredient-typeGlycopeptides

Suppliers and Packaging for NDA: 065455

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride
INJECTABLE;INJECTION 065455 ANDA Hospira, Inc. 0409-6510 0409-6510-01 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-6510-01) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Apr 29, 2009TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Julphar
Accenture
Cipla
Fish and Richardson
Citi
Express Scripts
UBS
Mallinckrodt
Queensland Health
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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