Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040431
Company: IMPAX LABS
Company: IMPAX LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUDROCORTISONE ACETATE | FLUDROCORTISONE ACETATE | 0.1MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/18/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40431ltr.pdf |
FLUDROCORTISONE ACETATE
TABLET;ORAL; 0.1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUDROCORTISONE ACETATE | FLUDROCORTISONE ACETATE | 0.1MG | TABLET;ORAL | Prescription | No | AB | 040425 | BARR |
FLUDROCORTISONE ACETATE | FLUDROCORTISONE ACETATE | 0.1MG | TABLET;ORAL | Prescription | No | AB | 040431 | IMPAX LABS |
FLUDROCORTISONE ACETATE | FLUDROCORTISONE ACETATE | 0.1MG | TABLET;ORAL | Prescription | No | AB | 215279 | NOVITIUM PHARMA |