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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 202260

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NDA 202260 describes NORETHINDRONE, which is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Lupin Ltd, Naari Pte, Novast Labs, Xiromed, Aurobindo Pharma Ltd, Barr, Barr Labs Inc, Dr Reddys Labs Sa, Apotex, Barr Labs, Watson Labs, Watson Pharms Teva, Mylan Labs Ltd, Watson Labs Teva, and Teva Branded Pharm, and is included in sixty-three NDAs. It is available from eleven suppliers. Additional details are available on the NORETHINDRONE profile page.

The generic ingredient in NORETHINDRONE is mestranol; norethindrone. There are eleven drug master file entries for this compound. Additional details are available on the mestranol; norethindrone profile page.

Summary for 202260

Tradename:	NORETHINDRONE
Applicant:	Amneal Pharms
Ingredient:	norethindrone
Patents:	0

Medical Subject Heading (MeSH) Categories for 202260

Contraceptives, Oral, Synthetic

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.35MG
Approval Date:	Aug 1, 2013	TE:		RLD:	No

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