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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040275
Company: EPIC PHARMA LLC

Products on ANDA 040275

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	0.5MG	TABLET;ORAL	Prescription	AB	No	No
ESTRADIOL	ESTRADIOL	1MG	TABLET;ORAL	Prescription	AB	No	No
ESTRADIOL	ESTRADIOL	2MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040275

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-275_Estradiol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40275ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040275_estradiol_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2024	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
01/04/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/24/1999	SUPPL-3	Labeling		Label is not available on this site.
11/01/1999	SUPPL-2	Labeling		Label is not available on this site.
11/01/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 040275

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/29/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-275_Estradiol_Prntlbl.pdf

Therapeutic Equivalents for ANDA 040275

ESTRADIOL

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.5MG	TABLET;ORAL	Prescription	No	AB	040197	BARR LABS INC
ESTRADIOL	ESTRADIOL	0.5MG	TABLET;ORAL	Prescription	No	AB	040275	EPIC PHARMA LLC
ESTRADIOL	ESTRADIOL	0.5MG	TABLET;ORAL	Prescription	No	AB	217334	NOVITIUM PHARMA

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	1MG	TABLET;ORAL	Prescription	No	AB	040197	BARR LABS INC
ESTRADIOL	ESTRADIOL	1MG	TABLET;ORAL	Prescription	No	AB	040275	EPIC PHARMA LLC
ESTRADIOL	ESTRADIOL	1MG	TABLET;ORAL	Prescription	No	AB	217334	NOVITIUM PHARMA

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	2MG	TABLET;ORAL	Prescription	No	AB	040197	BARR LABS INC
ESTRADIOL	ESTRADIOL	2MG	TABLET;ORAL	Prescription	No	AB	040275	EPIC PHARMA LLC
ESTRADIOL	ESTRADIOL	2MG	TABLET;ORAL	Prescription	No	AB	217334	NOVITIUM PHARMA

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