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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078892
Company: AMNEAL PHARMS

Products on ANDA 078892

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078892

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/2011	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078892

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

TABLET;ORAL; 0.035MG;0.4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEXESTA FE	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL	Prescription	No	AB	207535	AUROBINDO PHARMA
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL	Prescription	No	AB	078892	AMNEAL PHARMS
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL	Prescription	No	AB	078965	BARR
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL	Prescription	No	AB	091332	LUPIN LTD
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL	Prescription	No	AB	202086	MYLAN LABS LTD
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL	Prescription	No	AB	207066	NAARI PTE LTD

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