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Generated: May 26, 2017

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Details for New Drug Application (NDA): 062663

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NDA 062663 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: 062663

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 062663


Suppliers and Packaging for NDA: 062663

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
vancomycin hydrochloride
INJECTABLE;INJECTION 062663 ANDA Fresenius Kabi USA, LLC 63323-203 63323-203-20 10 VIAL in 1 TRAY (63323-203-20) > 15 mL in 1 VIAL
vancomycin hydrochloride
INJECTABLE;INJECTION 062663 ANDA Fresenius Kabi USA, LLC 63323-221 63323-221-16 25 VIAL in 1 TRAY (63323-221-16) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Mar 17, 1987TE:APRLD:No

Summary for product number 002

Approval Date:Jul 31, 1987TE:APRLD:No

Summary for product number 003

Approval Date:Jun 3, 1988TE:APRLD:No

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