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Generated: May 21, 2018

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
Tradename:FLUDROCORTISONE ACETATE
Applicant:Hikma Pharms
Ingredient:fludrocortisone acetate
Patents:0
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 N 0143-1246-01
FLUDROCORTISONE ACETATE fludrocortisone acetate TABLET;ORAL 091302 ANDA West-ward Pharmaceutical Corp 0143-1246 N 0143-1246-30

Profile for product number 001

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

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Baxter
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