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Last Updated: December 22, 2024

Suppliers and packages for generic ingredient: ethinyl estradiol; norethindrone acetate

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ethinyl estradiol; norethindrone acetate

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Xiromed	GEMMILY	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	213317	ANDA	Northstar Rx LLC	16714-155-03	3 CARTON in 1 CARTON (16714-155-03) / 1 BLISTER PACK in 1 CARTON (16714-155-01) / 1 KIT in 1 BLISTER PACK	2021-04-07
Xiromed	GEMMILY	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	213317	ANDA	Xiromed, LLC	70700-152-85	3 CARTON in 1 CARTON (70700-152-85) / 1 BLISTER PACK in 1 CARTON (70700-152-84) / 1 KIT in 1 BLISTER PACK	2020-11-09
Wilshire Pharms Inc	MERZEE	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	212706	ANDA	Lupin Pharmaceuticals, Inc.	43386-371-32	1 BLISTER PACK in 1 CARTON (43386-371-32) / 1 KIT in 1 BLISTER PACK	2022-03-09
Wilshire Pharms Inc	MERZEE	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	212706	ANDA	Slayback Pharma LLC	71225-130-01	1 BLISTER PACK in 1 CARTON (71225-130-01) / 1 KIT in 1 BLISTER PACK	2021-02-16
Amneal Pharms	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	214292	ANDA	Amneal Pharmaceuticals LLC	65162-558-15	5 CARTON in 1 TRAY (65162-558-15) / 1 BLISTER PACK in 1 CARTON (65162-558-58) / 1 KIT in 1 BLISTER PACK	2021-07-28
Amneal Pharms	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	214292	ANDA	Amneal Pharmaceuticals NY LLC	69238-1686-3	5 CARTON in 1 TRAY (69238-1686-3) / 1 BLISTER PACK in 1 CARTON (69238-1686-6) / 1 KIT in 1 BLISTER PACK	2021-07-26
Glenmark Pharms Ltd	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	213418	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-849-29	3 CARTON in 1 BOX (68462-849-29) / 1 BLISTER PACK in 1 CARTON (68462-849-84) / 1 KIT in 1 BLISTER PACK * 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-821-40) * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-822-40)	2022-07-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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