Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040431
Company: IMPAX LABS

Products on ANDA 040431

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040431

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

Therapeutic Equivalents for ANDA 040431

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	220308	HIBROW HLTHCARE
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
FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	0.1MG	TABLET;ORAL	Prescription	No	AB	219251	ZYDUS LIFESCIENCES