You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 205780


✉ Email this page to a colleague

« Back to Dashboard


NDA 205780 describes VANCOMYCIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings Pharm, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hainan Poly, Hainan Poly Pharm, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Meitheal, Mylan Labs Ltd, Pharm Assoc, Sagent Pharms, Sandoz, Sandoz Inc, Teva Pharms Usa, Xellia Pharms Aps, Zhejiang Novus Pharm, and Samson Medcl, and is included in fifty-two NDAs. It is available from twenty-five suppliers. There are five patents protecting this drug. 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. Thirty-one suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 205780
Tradename:VANCOMYCIN HYDROCHLORIDE
Applicant:Eugia Pharma
Ingredient:vancomycin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205780
Medical Subject Heading (MeSH) Categories for 205780
Suppliers and Packaging for NDA: 205780
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 205780 ANDA NorthStar Rx LLC 16714-247 16714-247-10 10 VIAL in 1 CARTON (16714-247-10) / 10 mL in 1 VIAL
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 205780 ANDA NorthStar Rx LLC 16714-309 16714-309-10 10 VIAL in 1 CARTON (16714-309-10) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Mar 31, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Mar 31, 2016TE:APRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.