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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205449
Company: AUROBINDO PHARMA LTD

Products on ANDA 205449

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205449

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/2025	SUPPL-4	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/29/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/25/2022	SUPPL-1	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205449

MILI

TABLET;ORAL-28; 0.035MG;0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTARYLLA	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	090794	XIROMED
MILI	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	205449	AUROBINDO PHARMA LTD
MONO-LINYAH	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	090523	NOVAST LABS LTD
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	200538	GLENMARK PHARMS LTD
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	205630	LUPIN
NORGESTIMATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	200384	NAARI PTE
SPRINTEC	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG	TABLET;ORAL-28	Prescription	No	AB	075804	BARR

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