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Details for New Drug Application (NDA): 085979

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NDA 085979 describes PRAMOSONE, which is a drug marketed by Ferndale Labs and Sebela Ireland Ltd and is included in five NDAs. It is available from two suppliers. Additional details are available on the PRAMOSONE profile page.

The generic ingredient in PRAMOSONE is hydrocortisone acetate; pramoxine hydrochloride. There are fifty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.

Summary for NDA: 085979

Sebela Ireland Ltd
hydrocortisone acetate; pramoxine hydrochloride
Therapeutic Class:Dermatological Agents

Pharmacology for NDA: 085979

Suppliers and Packaging for NDA: 085979

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrocortisone acetate; pramoxine hydrochloride
LOTION;TOPICAL 085979 ANDA Ferndale Laboratories, Inc. 0496-0726 0496-0726-04 118 mL in 1 BOTTLE, PLASTIC (0496-0726-04)
hydrocortisone acetate; pramoxine hydrochloride
LOTION;TOPICAL 085979 ANDA Ferndale Laboratories, Inc. 0496-0726 0496-0726-06 59 mL in 1 BOTTLE, PLASTIC (0496-0726-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength2.5%;1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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