Details for New Drug Application (NDA): 085368
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NDA 085368 describes PRAMOSONE, which is a drug marketed by Sebela Ireland Ltd and Ferndale Labs and is included in five NDAs. It is available from three suppliers. Additional details are available on the PRAMOSONE profile page.
The generic ingredient in PRAMOSONE is hydrocortisone acetate; pramoxine hydrochloride. There are sixty-seven drug master file entries for this compound. Four 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 are sixty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.
Summary for 085368
| Tradename: | PRAMOSONE |
| Applicant: | Sebela Ireland Ltd |
| Ingredient: | hydrocortisone acetate; pramoxine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 085368
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 085368
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRAMOSONE | hydrocortisone acetate; pramoxine hydrochloride | CREAM;TOPICAL | 085368 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-144 | 45802-144-64 | 1 TUBE in 1 CARTON (45802-144-64) / 28.35 g in 1 TUBE |
| PRAMOSONE | hydrocortisone acetate; pramoxine hydrochloride | CREAM;TOPICAL | 085368 | ANDA | Sebela Pharmaceuticals Inc. | 54766-716 | 54766-716-03 | 57 g in 1 TUBE (54766-716-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1%;1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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