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Generated: November 20, 2018

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Details for New Drug Application (NDA): 208910

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NDA 208910 describes FIRVANQ KIT, which is a drug marketed by Rxmtm Theraps Llc and is included in one NDA. It is available from one supplier. Additional details are available on the FIRVANQ KIT profile page.

The generic ingredient in FIRVANQ KIT is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 208910
Tradename:FIRVANQ KIT
Applicant:Rxmtm Theraps Llc
Ingredient:vancomycin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 208910
Suppliers and Packaging for NDA: 208910
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FIRVANQ KIT vancomycin hydrochloride FOR SOLUTION;ORAL 208910 NDA CutisPharma, Inc. 65628-204 65628-204-05 1 KIT in 1 CARTON (65628-204-05) * 3.75 g in 1 BOTTLE * 147 mL in 1 BOTTLE
FIRVANQ KIT vancomycin hydrochloride FOR SOLUTION;ORAL 208910 NDA CutisPharma, Inc. 65628-205 65628-205-10 1 KIT in 1 CARTON (65628-205-10) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 25MG BASE/ML
Approval Date:Jan 26, 2018TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 50MG BASE/ML
Approval Date:Jan 26, 2018TE:RLD:Yes

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