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.
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
