Details for New Drug Application (NDA): 219251
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NDA 219251 describes FLUDROCORTISONE ACETATE, which is a drug marketed by Barr, Chartwell Rx, Hikma Pharms, Impax Labs, Novitium Pharma, and Zydus Lifesciences, and is included in six NDAs. It is available from fourteen 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the fludrocortisone acetate profile page.
Summary for 219251
| Tradename: | FLUDROCORTISONE ACETATE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | fludrocortisone acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 219251
Suppliers and Packaging for NDA: 219251
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 219251 | ANDA | Zydus Lifesciences Limited | 70771-1893 | 70771-1893-1 | 100 TABLET in 1 BOTTLE (70771-1893-1) |
| FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 219251 | ANDA | Zydus Lifesciences Limited | 70771-1893 | 70771-1893-5 | 500 TABLET in 1 BOTTLE (70771-1893-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
| Approval Date: | Oct 16, 2024 | TE: | AB | RLD: | No | ||||
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