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Details for New Drug Application (NDA): 091302

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NDA 091302 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 eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the fludrocortisone acetate profile page.

Summary for NDA: 091302

Suppliers and Packaging for NDA: 091302

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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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