Last Updated: June 25, 2026

Details for New Drug Application (NDA): 078376

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NDA 078376 describes GILDAGIA, which is a drug marketed by Ph Health and is included in one NDA. Additional details are available on the GILDAGIA profile page.

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

Summary for 078376

Tradename:	GILDAGIA
Applicant:	Ph Health
Ingredient:	ethinyl estradiol; norethindrone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.035MG;0.4MG
Approval Date:	Nov 6, 2012	TE:		RLD:	No

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