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Last Updated: November 16, 2024

Details for New Drug Application (NDA): 204236

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NDA 204236 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, and Apotex, 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-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for 204236

Tradename:	NORETHINDRONE ACETATE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	norethindrone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jan 8, 2016	TE:		RLD:	No

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