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Details for New Drug Application (NDA): 200837

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NDA 200837 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-one 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-five suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.

Summary for NDA: 200837

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 200837


Suppliers and Packaging for NDA: 200837

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
vancomycin hydrochloride
INJECTABLE;INJECTION 200837 ANDA Sagent Pharmaceuticals 25021-157 25021-157-99 1 BOTTLE in 1 CARTON (25021-157-99) > 100 mL in 1 BOTTLE
vancomycin hydrochloride
INJECTABLE;INJECTION 200837 ANDA Sagent Pharmaceuticals 25021-158 25021-158-99 1 BOTTLE in 1 CARTON (25021-158-99) > 100 mL in 1 BOTTLE

Summary for product number 001

Approval Date:Aug 10, 2012TE:APRLD:No

Summary for product number 002

Approval Date:Sep 2, 2014TE:APRLD:No

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