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Generated: October 22, 2018

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Details for New Drug Application (NDA): 091532

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NDA 091532 describes VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER, which is a drug marketed by Samson Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER profile page.

The generic ingredient in VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 091532
Tradename:VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Applicant:Samson Medcl
Ingredient:vancomycin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091532
Ingredient-typeGlycopeptides
Medical Subject Heading (MeSH) Categories for 091532
Suppliers and Packaging for NDA: 091532
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER vancomycin hydrochloride POWDER;IV (INFUSION) 091532 ANDA SAMSON MEDICAL TECHNOLOGIES LLC 66288-7100 66288-7100-1 1 BAG in 1 BAG (66288-7100-1) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)StrengthEQ 100GM BASE
Approval Date:Jan 6, 2016TE:RLD:No

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