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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203873
Company: AMNEAL PHARMS

Products on ANDA 203873

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203873

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/12/2016	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203873Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203873

NORGESTIMATE AND ETHINYL ESTRADIOL

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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