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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 211962


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NDA 211962 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 211962
Tradename:VANCOMYCIN HYDROCHLORIDE
Applicant:Xellia Pharms Aps
Ingredient:vancomycin hydrochloride
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 211962
Medical Subject Heading (MeSH) Categories for 211962
Suppliers and Packaging for NDA: 211962
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride SOLUTION;INTRAVENOUS 211962 NDA Xellia Pharmaceuticals USA LLC 70594-041 70594-041-02 6 BAG in 1 CARTON (70594-041-02) / 100 mL in 1 BAG (70594-041-01)
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride SOLUTION;INTRAVENOUS 211962 NDA Xellia Pharmaceuticals USA LLC 70594-041 70594-041-03 12 BAG in 1 CARTON (70594-041-03) / 100 mL in 1 BAG (70594-041-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 500MG BASE/100ML (EQ 5MG BASE/ML)
Approval Date:Feb 15, 2019TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Nov 6, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS
Patent:⤷  Try a TrialPatent Expiration:Nov 6, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS
Patent:⤷  Try a TrialPatent Expiration:Nov 6, 2035Product Flag?YSubstance Flag?Delist Request?

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