Details for New Drug Application (NDA): 040425
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The generic ingredient in FLUDROCORTISONE ACETATE is fludrocortisone acetate. There are four drug master file entries for this compound. Fourteen 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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