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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205694

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NDA 205694 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, 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-four NDAs. It is available from twenty-three 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-seven suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 205694
Applicant:Gland Pharma Ltd
Ingredient:vancomycin hydrochloride
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 205694
Medical Subject Heading (MeSH) Categories for 205694
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 Alvogen Inc. 47781-597 N 47781-597-91
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 205694 ANDA Alvogen Inc. 47781-598 N 47781-598-91

Profile for product number 001

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

Profile for product number 002

Approval Date:Jan 21, 2016TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Boehringer Ingelheim
Express Scripts
Cantor Fitzgerald

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