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Serving leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091302

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NDA 091302 describes FLUDROCORTISONE ACETATE, which is a drug marketed by Barr, Hikma Pharms, and Impax Labs, and is included in three NDAs. It is available from ten suppliers. Additional details are available on the FLUDROCORTISONE ACETATE profile page.

The generic ingredient in FLUDROCORTISONE ACETATE is fludrocortisone acetate. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fludrocortisone acetate profile page.

Summary for 091302

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 091302

Suppliers and Packaging for NDA: 091302

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDROCORTISONE ACETATE fludrocortisone acetate TABLET;ORAL 091302 ANDA West-ward Pharmaceutical Corp 0143-1246 0143-1246-01 100 TABLET in 1 BOTTLE (0143-1246-01)
FLUDROCORTISONE ACETATE fludrocortisone acetate TABLET;ORAL 091302 ANDA West-ward Pharmaceutical Corp 0143-1246 0143-1246-30 30 TABLET in 1 BOTTLE (0143-1246-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Jul 22, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Fish and Richardson
US Army
Boehringer Ingelheim
Argus Health
Federal Trade Commission

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