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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 050671


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NDA 050671 describes VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER, which is a drug marketed by Samson Medcl and Baxter Hlthcare and is included in two NDAs. It is available from two suppliers. 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. Thirty suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 050671
Pharmacology for NDA: 050671
Medical Subject Heading (MeSH) Categories for 050671
Suppliers and Packaging for NDA: 050671
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER vancomycin hydrochloride SOLUTION;INTRAVENOUS 050671 NDA Baxter Healthcare Corporation 0338-0122 0338-0122-04 250 mL in 1 BAG (0338-0122-04)
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER vancomycin hydrochloride SOLUTION;INTRAVENOUS 050671 NDA Baxter Healthcare Corporation 0338-0124 0338-0124-04 300 mL in 1 BAG (0338-0124-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 500MG BASE/100ML (EQ 5MG BASE/ML)
Approval Date:Apr 29, 1993TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 750MG BASE/150ML (EQ 5MG BASE/ML)
Approval Date:Dec 20, 2010TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 1GM BASE/200ML (EQ 5MG BASE/ML)
Approval Date:Mar 1, 1999TE:RLD:Yes

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