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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200910
Company: MYLAN TECHNOLOGIES

Products on ANDA 200910

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XULANE	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200910

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/2014	ORIG-1	Approval	Not Applicable		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200910Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-14	Labeling-Package Insert, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/31/2020	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/24/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/09/2017	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/14/2017	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/14/2017	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200910

XULANE

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.035MG/24HR;0.15MG/24HR
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETHINYL ESTRADIOL AND NORELGESTROMIN	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB	213950	AMNEAL
ETHINYL ESTRADIOL AND NORELGESTROMIN	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB	214594	ZYDUS NOVELTECH INC
ONSURA	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB	213977	TEVA PHARMS USA
XULANE	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB	200910	MYLAN TECHNOLOGIES

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