Details for New Drug Application (NDA): 215279
✉ Email this page to a colleague
The generic ingredient in FLUDROCORTISONE ACETATE is fludrocortisone acetate. There are four drug master file entries for this compound. Eleven 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 |
Formulation / Manufacturing: | see details |
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 | Novitium Pharma LLC | 70954-252 | 70954-252-10 | 30 TABLET in 1 BOTTLE (70954-252-10) |
FLUDROCORTISONE ACETATE | fludrocortisone acetate | TABLET;ORAL | 215279 | ANDA | Novitium Pharma LLC | 70954-252 | 70954-252-20 | 100 TABLET in 1 BOTTLE (70954-252-20) |
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 |
Complete Access Available with Subscription