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Details for New Drug Application (NDA): 040425

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NDA 040425 describes FLUDROCORTISONE ACETATE, which is a drug marketed by Hikma Pharms, Barr, 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 NDA: 040425

Tradename:
FLUDROCORTISONE ACETATE
Applicant:
Barr
Ingredient:
fludrocortisone acetate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

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 0555-0997-02 100 TABLET in 1 BOTTLE (0555-0997-02)
FLUDROCORTISONE ACETATE
fludrocortisone acetate
TABLET;ORAL 040425 ANDA PD-Rx Pharmaceuticals, Inc. 43063-714 43063-714-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-714-60)

Summary for product number 001

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


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