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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200383
Company: NAARI PTE LTD

Products on ANDA 200383

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200383

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/2015	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2023	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/29/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/02/2022	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/02/2022	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200383

NORGESTIMATE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;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	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	200494	GLENMARK PHARMS LTD
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	205588	LUPIN LTD
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	200383	NAARI PTE LTD
TRI-ESTARYLLA	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	090793	XIROMED
TRI-LINYAH	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	090524	NOVAST LABS LTD
TRI-MILI	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	205441	AUROBINDO PHARMA LTD
TRI-SPRINTEC	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	TABLET;ORAL-28	Prescription	No	AB	075808	BARR

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