Last Updated: November 9, 2026

Details for New Drug Application (NDA): 091090

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NDA 091090 describes NORETHINDRONE ACETATE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Glenmark Pharms Ltd, Ingenus Pharms Llc, Xiromed, Barr Labs Inc, Dr Reddys Labs Sa, Apotex, and Barr Labs, and is included in twenty-nine NDAs. It is available from eight suppliers. Additional details are available on the NORETHINDRONE ACETATE profile page.

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

Summary for 091090

Tradename:	NORETHINDRONE ACETATE
Applicant:	Glenmark Pharms Ltd
Ingredient:	norethindrone acetate
Patents:	0

Pharmacology for NDA: 091090

Suppliers and Packaging for NDA: 091090

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	091090	ANDA	American Health Packaging	60687-921	60687-921-21	30 BLISTER PACK in 1 CARTON (60687-921-21) / 1 TABLET in 1 BLISTER PACK (60687-921-11)
NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	091090	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-304	68462-304-05	500 TABLET in 1 BOTTLE (68462-304-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jul 21, 2010	TE:	AB	RLD:	No

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