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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202980
Company: LUPIN LTD

Products on ANDA 202980

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TURQOZ	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202980

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2023	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202980

TURQOZ

TABLET;ORAL-28; 0.03MG;0.3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CRYSELLE	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	075840	DURAMED PHARMS BARR
ELINEST	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	091105	NOVAST LABS LTD
LOW-OGESTREL-28	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	075288	DR REDDYS LABS SA
TURQOZ	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	202980	LUPIN LTD

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