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Generated: November 21, 2018

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Details for New Drug Application (NDA): 204107

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NDA 204107 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, Hikma Pharms, 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-six 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-two 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 204107
Tradename:VANCOMYCIN HYDROCHLORIDE
Applicant:Cft Pharms Llc
Ingredient:vancomycin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204107
Ingredient-typeGlycopeptides
Medical Subject Heading (MeSH) Categories for 204107
Suppliers and Packaging for NDA: 204107
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 204107 ANDA Fresenius Kabi, LLC 63323-221 63323-221-10 25 VIAL in 1 TRAY (63323-221-10) > 10 mL in 1 VIAL
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 204107 ANDA Fresenius Kabi, LLC 63323-221 63323-221-16 25 VIAL in 1 TRAY (63323-221-16) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Dec 28, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Dec 28, 2015TE:APRLD:No

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