Details for New Drug Application (NDA): 086195
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NDA 086195 describes PROCTOFOAM HC, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. Additional details are available on the PROCTOFOAM HC profile page.
The generic ingredient in PROCTOFOAM HC 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 PROCTOFOAM HC 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 086195
| Tradename: | PROCTOFOAM HC |
| Applicant: | Mylan Speciality Lp |
| Ingredient: | hydrocortisone acetate; pramoxine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 086195
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 086195
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROCTOFOAM HC | hydrocortisone acetate; pramoxine hydrochloride | AEROSOL, METERED;TOPICAL | 086195 | ANDA | Meda Pharmaceuticals Inc. | 0037-6822 | 0037-6822-10 | 1 CANISTER in 1 CARTON (0037-6822-10) / 10 g in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;TOPICAL | Strength | 1%;1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | BX | RLD: | Yes | ||||
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