Details for New Drug Application (NDA): 215279
NDA 215279 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 215279
| Tradename: | FLUDROCORTISONE ACETATE |
| Applicant: | Novitium Pharma |
| Ingredient: | fludrocortisone acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 215279
Suppliers and Packaging for NDA: 215279
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 215279 | ANDA | Major Pharmaceuticals | 0904-7317 | 0904-7317-06 | 50 BLISTER PACK in 1 CARTON (0904-7317-06) / 1 TABLET in 1 BLISTER PACK |
| FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 215279 | ANDA | Major Pharmaceuticals | 0904-7317 | 0904-7317-61 | 100 BLISTER PACK in 1 CARTON (0904-7317-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
| Approval Date: | May 31, 2022 | TE: | AB | RLD: | No | ||||
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