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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090439


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NDA 090439 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, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sandoz Inc, Slate Run Pharma, Teva Pharms Usa, Xellia Pharms Aps, Zhejiang Novus Pharm, Samson Medcl, and Baxter Hlthcare, and is included in fifty-three 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 suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 090439
Tradename:VANCOMYCIN HYDROCHLORIDE
Applicant:Lupin Ltd
Ingredient:vancomycin hydrochloride
Patents:0
Pharmacology for NDA: 090439
Medical Subject Heading (MeSH) Categories for 090439
Suppliers and Packaging for NDA: 090439
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride CAPSULE;ORAL 090439 ANDA Lupin Pharmaceuticals, Inc. 68180-166 68180-166-13 2 BLISTER PACK in 1 CARTON (68180-166-13) / 10 CAPSULE in 1 BLISTER PACK
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride CAPSULE;ORAL 090439 ANDA Lupin Pharmaceuticals, Inc. 68180-167 68180-167-13 2 BLISTER PACK in 1 CARTON (68180-167-13) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 125MG BASE
Approval Date:Jan 28, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Jan 28, 2015TE:ABRLD:No

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