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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065397

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NDA 065397 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 065397

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

Pharmacology for NDA: 065397

Ingredient-typeGlycopeptides

Medical Subject Heading (MeSH) Categories for 065397

Suppliers and Packaging for NDA: 065397

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 065397 ANDA Pfizer Laboratories Div Pfizer Inc 0069-2587 0069-2587-10 10 VIAL in 1 CARTON (0069-2587-10) > 10 mL in 1 VIAL (0069-2587-03)
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 065397 ANDA Pfizer Laboratories Div Pfizer Inc 0069-2589 0069-2589-10 10 VIAL in 1 CARTON (0069-2589-10) > 20 mL in 1 VIAL (0069-2589-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Dec 30, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Dec 30, 2008TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Citi
Mallinckrodt
Teva
Daiichi Sankyo
AstraZeneca
Colorcon
QuintilesIMS
Moodys
Fuji

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