Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214594
Company: ZYDUS NOVELTECH INC

Products on ANDA 214594

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214594

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/14/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214594

ETHINYL ESTRADIOL AND NORELGESTROMIN

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