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Details for New Drug Application (NDA): 205694

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NDA 205694 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: 205694

Tradename:
VANCOMYCIN HYDROCHLORIDE
Applicant:
Gland Pharma Ltd
Ingredient:
vancomycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 205694

Ingredient-typeGlycopeptides

Suppliers and Packaging for NDA: 205694

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride
INJECTABLE;INJECTION 205694 ANDA Gland Pharma Limited 68083-143 68083-143-25 25 VIAL in 1 CARTON (68083-143-25) > 10 mL in 1 VIAL
VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride
INJECTABLE;INJECTION 205694 ANDA Gland Pharma Limited 68083-144 68083-144-10 10 VIAL in 1 CARTON (68083-144-10) > 20 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jan 21, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jan 21, 2016TE:APRLD:No


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