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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 040091


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NDA 040091 describes SULFADIAZINE, which is a drug marketed by Abbvie, Chartwell Molecular, Epic Pharma Llc, Everylife, Impax Labs, Lederle, and Lilly, and is included in seven NDAs. It is available from two suppliers. Additional details are available on the SULFADIAZINE profile page.

The generic ingredient in SULFADIAZINE is sulfadiazine sodium. There are nineteen drug master file entries for this compound. Additional details are available on the sulfadiazine sodium profile page.
Summary for 040091
Tradename:SULFADIAZINE
Applicant:Epic Pharma Llc
Ingredient:sulfadiazine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040091
Medical Subject Heading (MeSH) Categories for 040091
Suppliers and Packaging for NDA: 040091
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFADIAZINE sulfadiazine TABLET;ORAL 040091 ANDA Eon Labs, Inc. 0185-0757 0185-0757-01 100 TABLET in 1 BOTTLE (0185-0757-01)
SULFADIAZINE sulfadiazine TABLET;ORAL 040091 ANDA EPIC PHARMA, LLC 42806-757 42806-757-60 60 TABLET in 1 BOTTLE (42806-757-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 29, 1994TE:RLD:No

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