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Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040425

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NDA 040425 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 040425
Ingredient:fludrocortisone acetate
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040425
Suppliers and Packaging for NDA: 040425
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUDROCORTISONE ACETATE fludrocortisone acetate TABLET;ORAL 040425 ANDA Teva Pharmaceuticals USA, Inc. 0555-0997 N 0555-0997-02
FLUDROCORTISONE ACETATE fludrocortisone acetate TABLET;ORAL 040425 ANDA PD-Rx Pharmaceuticals, Inc. 43063-714 N 43063-714-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Jan 21, 2003TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
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US Army
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