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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076166
Company: MYLAN TECHNOLOGIES

Products on ANDA 076166

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLONIDINE	CLONIDINE	0.1MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB	No	No
CLONIDINE	CLONIDINE	0.2MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB	No	No
CLONIDINE	CLONIDINE	0.3MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076166

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2023	SUPPL-19	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
05/18/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/24/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076166

CLONIDINE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CATAPRES-TTS-1	CLONIDINE	0.1MG/24HR	SYSTEM;TRANSDERMAL	Prescription	Yes	AB	018891	LAVIPHARM
CLONIDINE	CLONIDINE	0.1MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	090873	ACTAVIS LABS UT INC
CLONIDINE	CLONIDINE	0.1MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	079090	DR REDDYS LABS SA
CLONIDINE	CLONIDINE	0.1MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	076166	MYLAN TECHNOLOGIES

SYSTEM;TRANSDERMAL; 0.2MG/24HR
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CATAPRES-TTS-2	CLONIDINE	0.2MG/24HR	SYSTEM;TRANSDERMAL	Prescription	Yes	AB	018891	LAVIPHARM
CLONIDINE	CLONIDINE	0.2MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	090873	ACTAVIS LABS UT INC
CLONIDINE	CLONIDINE	0.2MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	079090	DR REDDYS LABS SA
CLONIDINE	CLONIDINE	0.2MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	076166	MYLAN TECHNOLOGIES

SYSTEM;TRANSDERMAL; 0.3MG/24HR
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CATAPRES-TTS-3	CLONIDINE	0.3MG/24HR	SYSTEM;TRANSDERMAL	Prescription	Yes	AB	018891	LAVIPHARM
CLONIDINE	CLONIDINE	0.3MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	090873	ACTAVIS LABS UT INC
CLONIDINE	CLONIDINE	0.3MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	079090	DR REDDYS LABS SA
CLONIDINE	CLONIDINE	0.3MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	076166	MYLAN TECHNOLOGIES

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