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Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085980

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NDA 085980 describes PRAMOSONE, which is a drug marketed by Ferndale Labs and Sebela Ireland Ltd and is included in five NDAs. It is available from one supplier. Additional details are available on the PRAMOSONE profile page.

The generic ingredient in PRAMOSONE is hydrocortisone acetate; pramoxine hydrochloride. There are sixty 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 NDA: 085980

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 085980

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 54766-729-03 236 mL in 1 BOTTLE (54766-729-03)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength1%;1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
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Dow

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