Details for New Drug Application (NDA): 219251
NDA 219251 describes FLUDROCORTISONE ACETATE, which is a drug marketed by Adaptis, Barr, Chartwell Rx, Hikma Pharms, Impax Labs, Novitium Pharma, and Zydus Lifesciences, and is included in seven NDAs. It is available from fifteen suppliers. Additional details are available on the FLUDROCORTISONE ACETATE profile page.
The generic ingredient in FLUDROCORTISONE ACETATE is fludrocortisone acetate. There is one drug master file entry for this compound. Fifteen 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 is one drug master file entry for this compound. Fifteen 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 | Golden State Medical Supply, Inc. | 51407-705 | 51407-705-01 | 100 TABLET in 1 BOTTLE (51407-705-01) |
| FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 219251 | ANDA | Zydus Lifesciences Limited | 70771-1893 | 70771-1893-1 | 100 TABLET in 1 BOTTLE (70771-1893-1) |
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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