Details for New Drug Application (NDA): 085980
✉ Email this page to a colleague
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 085980
Tradename: | PRAMOSONE |
Applicant: | Sebela Ireland Ltd |
Ingredient: | hydrocortisone acetate; pramoxine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 085980
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 085980
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAMOSONE | hydrocortisone acetate; pramoxine hydrochloride | LOTION;TOPICAL | 085980 | ANDA | Sebela Pharmaceuticals Inc. | 54766-729 | 54766-729-04 | 118 mL in 1 BOTTLE (54766-729-04) |
PRAMOSONE | hydrocortisone acetate; pramoxine hydrochloride | LOTION;TOPICAL | 085980 | ANDA | Sebela Pharmaceuticals Inc. | 54766-729 | 54766-729-06 | 59 mL in 1 BOTTLE (54766-729-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 1%;1% | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Complete Access Available with Subscription