Suppliers and packages for NDA: 085979
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085979
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
---|---|---|---|---|---|---|---|---|---|
Sebela Ireland Ltd | PRAMOSONE | hydrocortisone acetate; pramoxine hydrochloride | LOTION;TOPICAL | 085979 | ANDA | Sebela Pharmaceuticals Inc. | 54766-726-04 | 118 mL in 1 BOTTLE, PLASTIC (54766-726-04) | 2014-10-16 |
Sebela Ireland Ltd | PRAMOSONE | hydrocortisone acetate; pramoxine hydrochloride | LOTION;TOPICAL | 085979 | ANDA | Sebela Pharmaceuticals Inc. | 54766-726-06 | 59 mL in 1 BOTTLE, PLASTIC (54766-726-06) | 2014-10-16 |
Sebela Ireland Ltd | PRAMOSONE | hydrocortisone acetate; pramoxine hydrochloride | LOTION;TOPICAL | 085979 | ANDA | Sebela Pharmaceuticals Inc. | 54766-829-04 | 59 mL in 1 BOTTLE, PLASTIC (54766-829-04) | 2015-08-05 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |