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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 203339

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NDA 203339 describes AMABELZ, which is a drug marketed by Lupin Ltd and is included in one NDA. Additional details are available on the AMABELZ profile page.

The generic ingredient in AMABELZ is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

Summary for 203339

Tradename:	AMABELZ
Applicant:	Lupin Ltd
Ingredient:	estradiol; norethindrone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG;0.1MG
Approval Date:	Jun 20, 2016	TE:	BX	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG;0.5MG
Approval Date:	Jun 20, 2016	TE:	BX	RLD:	No

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