Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075233
Company: MYLAN TECHNOLOGIES

Products on ANDA 075233

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE; TRANSDERMAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075233

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75233ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75233_Estradiol.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2006	SUPPL-12	Labeling		Label is not available on this site.
10/06/2005	SUPPL-11	Labeling		Label is not available on this site.
03/04/2005	SUPPL-10	Labeling		Label is not available on this site.
01/21/2005	SUPPL-9	Labeling		Label is not available on this site.
01/06/2005	SUPPL-7	Labeling		Label is not available on this site.
12/23/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/23/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/25/2001	SUPPL-2	Labeling		Label is not available on this site.
11/20/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075233

ESTRADIOL

FILM, EXTENDED RELEASE; TRANSDERMAL; 0.05MG/24HR
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE; TRANSDERMAL	Prescription	No	AB2	075233	MYLAN TECHNOLOGIES