Last Updated: November 9, 2026

Details for New Drug Application (NDA): 220876

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NDA 220876 describes NORGESTIMATE AND ETHINYL ESTRADIOL, which is a drug marketed by Annora Pharma, Glenmark Pharms Ltd, Glenmark Speclt, Lupin, Lupin Pharms, Mylan, Naari Pte, Watson Labs, and Xiromed, and is included in eighteen NDAs. It is available from seven suppliers. Additional details are available on the NORGESTIMATE AND ETHINYL ESTRADIOL profile page.

The generic ingredient in NORGESTIMATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norgestimate. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

Summary for 220876

Tradename:	NORGESTIMATE AND ETHINYL ESTRADIOL
Applicant:	Annora Pharma
Ingredient:	ethinyl estradiol; norgestimate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL-28			Strength	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Approval Date:	Sep 23, 2026	TE:	AB	RLD:	No

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