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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 205278

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NDA 205278 describes NORETHINDRONE ACETATE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Glenmark Pharms Ltd, Novast Labs, Xiromed, Barr Labs Inc, Dr Reddys Labs Sa, Apotex, and Barr Labs, and is included in twenty-nine NDAs. It is available from seven suppliers. Additional details are available on the NORETHINDRONE ACETATE profile page.

The generic ingredient in NORETHINDRONE ACETATE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for 205278

Tradename:	NORETHINDRONE ACETATE
Applicant:	Xiromed
Ingredient:	norethindrone acetate
Patents:	0

Pharmacology for NDA: 205278

Suppliers and Packaging for NDA: 205278

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	205278	ANDA	Xiromed LLC	70700-326	70700-326-50	50 TABLET in 1 BOTTLE (70700-326-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Nov 10, 2016	TE:	AB	RLD:	No

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