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Details for New Drug Application (NDA): 065453

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NDA 065453 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 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-four suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.

Summary for NDA: 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

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

Summary for product number 001

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

Summary for product number 002

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


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