Details for New Drug Application (NDA): 085979
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NDA 085979 describes PRAMOSONE, which is a drug marketed by Legacy and Ferndale Labs and is included in five NDAs. It is available from four suppliers. Additional details are available on the PRAMOSONE profile page.
The generic ingredient in PRAMOSONE is hydrocortisone acetate; pramoxine hydrochloride. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.
The generic ingredient in PRAMOSONE is hydrocortisone acetate; pramoxine hydrochloride. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.
Summary for 085979
| Tradename: | PRAMOSONE |
| Applicant: | Legacy |
| Ingredient: | hydrocortisone acetate; pramoxine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 085979
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 085979
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRAMOSONE | hydrocortisone acetate; pramoxine hydrochloride | LOTION;TOPICAL | 085979 | ANDA | Sebela Pharmaceuticals Inc. | 54766-829 | 54766-829-04 | 59 mL in 1 BOTTLE, PLASTIC (54766-829-04) |
| PRAMOSONE | hydrocortisone acetate; pramoxine hydrochloride | LOTION;TOPICAL | 085979 | ANDA | Legacy Pharma USA Inc. | 83107-019 | 83107-019-12 | 12 TUBE, WITH APPLICATOR in 1 CARTON (83107-019-12) / 4 g in 1 TUBE, WITH APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 2.5%;1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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