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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 061667


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NDA 061667 describes VANCOCIN HYDROCHLORIDE, which is a drug marketed by Ani Pharms and Steriscience Speclts and is included in six NDAs. It is available from two suppliers. Additional details are available on the VANCOCIN HYDROCHLORIDE profile page.

The generic ingredient in VANCOCIN 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 061667
Tradename:VANCOCIN HYDROCHLORIDE
Applicant:Ani Pharms
Ingredient:vancomycin hydrochloride
Patents:0
Pharmacology for NDA: 061667
Medical Subject Heading (MeSH) Categories for 061667
Suppliers and Packaging for NDA: 061667
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOCIN HYDROCHLORIDE vancomycin hydrochloride FOR SOLUTION;ORAL 061667 ANDA ANI Pharmaceuticals, Inc. 62559-830 62559-830-03 300 mL in 1 BOTTLE, PLASTIC (62559-830-03)
VANCOCIN HYDROCHLORIDE vancomycin hydrochloride FOR SOLUTION;ORAL 061667 ANDA ANI Pharmaceuticals, Inc. 62559-830 62559-830-55 150 mL in 1 BOTTLE, PLASTIC (62559-830-55)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrengthEQ 500MG BASE/6ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Jul 13, 1983TE:AARLD:No

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