Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201675
Company: MYLAN TECHNOLOGIES

Products on ANDA 201675

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	0.025MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB1	No	No
ESTRADIOL	ESTRADIOL	0.0375MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB1	No	No
ESTRADIOL	ESTRADIOL	0.05MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB1	No	No
ESTRADIOL	ESTRADIOL	0.075MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB1	No	No
ESTRADIOL	ESTRADIOL	0.1MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201675

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2014	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/08/2024	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/14/2018	SUPPL-6	Labeling-Proprietary Name Change		Label is not available on this site.
08/14/2018	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201675

ESTRADIOL

SYSTEM;TRANSDERMAL; 0.025MG/24HR
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.025MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	211293	AMNEAL
ESTRADIOL	ESTRADIOL	0.025MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	201675	MYLAN TECHNOLOGIES
ESTRADIOL	ESTRADIOL	0.025MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	206241	ZYDUS PHARMS
VIVELLE-DOT	ESTRADIOL	0.025MG/24HR	SYSTEM;TRANSDERMAL	Prescription	Yes	AB1	020538	SANDOZ

SYSTEM;TRANSDERMAL; 0.0375MG/24HR
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.0375MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	211293	AMNEAL
ESTRADIOL	ESTRADIOL	0.0375MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	201675	MYLAN TECHNOLOGIES
ESTRADIOL	ESTRADIOL	0.0375MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	206241	ZYDUS PHARMS
VIVELLE-DOT	ESTRADIOL	0.0375MG/24HR	SYSTEM;TRANSDERMAL	Prescription	Yes	AB1	020538	SANDOZ

SYSTEM;TRANSDERMAL; 0.05MG/24HR
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.05MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	211293	AMNEAL
ESTRADIOL	ESTRADIOL	0.05MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	201675	MYLAN TECHNOLOGIES
ESTRADIOL	ESTRADIOL	0.05MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	206241	ZYDUS PHARMS
VIVELLE-DOT	ESTRADIOL	0.05MG/24HR	SYSTEM;TRANSDERMAL	Prescription	Yes	AB1	020538	SANDOZ

SYSTEM;TRANSDERMAL; 0.075MG/24HR
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.075MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	211293	AMNEAL
ESTRADIOL	ESTRADIOL	0.075MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	201675	MYLAN TECHNOLOGIES
ESTRADIOL	ESTRADIOL	0.075MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	206241	ZYDUS PHARMS
VIVELLE-DOT	ESTRADIOL	0.075MG/24HR	SYSTEM;TRANSDERMAL	Prescription	Yes	AB1	020538	SANDOZ

SYSTEM;TRANSDERMAL; 0.1MG/24HR
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.1MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	211293	AMNEAL
ESTRADIOL	ESTRADIOL	0.1MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	201675	MYLAN TECHNOLOGIES
ESTRADIOL	ESTRADIOL	0.1MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB1	206241	ZYDUS PHARMS
VIVELLE-DOT	ESTRADIOL	0.1MG/24HR	SYSTEM;TRANSDERMAL	Prescription	Yes	AB1	020538	SANDOZ