An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202770
Company: XIROMED

Products on ANDA 202770

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202770

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/2015	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
04/24/2024	SUPPL-9	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/24/2024	SUPPL-7	Labeling-Patient Package Insert		Label is not available on this site.
11/08/2018	SUPPL-3	Labeling-Proprietary Name Change, Labeling-Container/Carton Labels		Label is not available on this site.
11/08/2018	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202770

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

TABLET;ORAL-21; 0.03MG;1.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUROVELA 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	No	AB	207581	AUROBINDO PHARMA
HAILEY 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	No	AB	209297	GLENMARK PHARMS
JUNEL 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	No	AB	076381	BARR
LARIN 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	No	AB	202996	NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	No	AB	202770	XIROMED

Top