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Last Updated: November 22, 2024

Suppliers and packages for generic ingredient: HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

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HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

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
Mylan Speciality Lp	EPIFOAM	hydrocortisone acetate; pramoxine hydrochloride	AEROSOL, METERED;TOPICAL	086457	ANDA	Meda Pharmaceuticals Inc.	0037-6824-10	1 CANISTER in 1 CARTON (0037-6824-10) / 10 g in 1 CANISTER	2014-08-25
Mylan Speciality Lp	PROCTOFOAM HC	hydrocortisone acetate; pramoxine hydrochloride	AEROSOL, METERED;TOPICAL	086195	ANDA	Meda Pharmaceuticals Inc.	0037-6822-10	1 CANISTER in 1 CARTON (0037-6822-10) / 10 g in 1 CANISTER	2014-08-15
Sebela Ireland Ltd	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-144-64	1 TUBE in 1 CARTON (45802-144-64) / 28.35 g in 1 TUBE	2010-04-13
Sebela Ireland Ltd	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Sebela Pharmaceuticals Inc.	54766-716-03	57 g in 1 TUBE (54766-716-03)	2015-08-04
Sebela Ireland Ltd	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Sebela Pharmaceuticals Inc.	54766-716-04	28.4 g in 1 TUBE (54766-716-04)	2015-08-04
Sebela Ireland Ltd	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Sebela Pharmaceuticals Inc.	54766-778-04	28.4 g in 1 TUBE, WITH APPLICATOR (54766-778-04)	2015-08-05
Sebela Ireland Ltd	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Bryant Ranch Prepack	63629-8669-1	1 TUBE in 1 CARTON (63629-8669-1) / 28.35 g in 1 TUBE	2010-04-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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