Details for New Drug Application (NDA): 040425
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NDA 040425 describes FLUDROCORTISONE ACETATE, which is a drug marketed by Barr, Chartwell Rx, Hikma Pharms, Impax Labs, and Novitium Pharma, and is included in five NDAs. It is available from twelve 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. Twelve suppliers are listed for this compound. 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. Twelve suppliers are listed for this compound. Additional details are available on the fludrocortisone acetate profile page.
Summary for 040425
| Tradename: | FLUDROCORTISONE ACETATE |
| Applicant: | Barr |
| Ingredient: | fludrocortisone acetate |
| Patents: | 0 |
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 | 0555-0997-02 | 100 TABLET in 1 BOTTLE (0555-0997-02) |
| FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 040425 | ANDA | Bryant Ranch Prepack | 63629-8806 | 63629-8806-1 | 100 TABLET in 1 BOTTLE (63629-8806-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
| Approval Date: | Jan 21, 2003 | TE: | AB | RLD: | No | ||||
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