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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090541
Company: NOVAST LABS

Products on ANDA 090541

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRI-LO-LINYAH	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	AB	No	No
TRI-LO-LINYAH	NORGESTIMATE; ETHINYL ESTRADIOL	0.215MG; 0.025MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
TRI-LO-LINYAH	NORGESTIMATE; ETHINYL ESTRADIOL	0.25MG; 0.025MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090541

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/02/2022	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 090541

TRI-LO-LINYAH

TABLET;ORAL-28; 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	203873	AMNEAL PHARMS
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	204057	GLENMARK PHARMS
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	200541	LUPIN PHARMS
TRI LO SPRINTEC	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	076784	BARR LABS INC
TRI-LO-ESTARYLLA	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	091232	XIROMED
TRI-LO-LINYAH	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	090541	NOVAST LABS
TRI-LO-MILI	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	205762	AUROBINDO PHARMA

TRI-LO-LINYAH

TABLET;ORAL-28; 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	203873	AMNEAL PHARMS
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	204057	GLENMARK PHARMS
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	200541	LUPIN PHARMS
TRI LO SPRINTEC	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	076784	BARR LABS INC
TRI-LO-ESTARYLLA	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	091232	XIROMED
TRI-LO-LINYAH	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	090541	NOVAST LABS
TRI-LO-MILI	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	205762	AUROBINDO PHARMA

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