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Details for New Drug Application (NDA): 204125

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NDA 204125 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, Eurohlth Intl Sarl, 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 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: 204125

Cft Pharms Llc
vancomycin hydrochloride
Therapeutic Class:Antibacterials

Summary for product number 001

Approval Date:Dec 28, 2015TE:APRLD:No

Summary for product number 002

Approval Date:Dec 28, 2015TE:APRLD:No

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