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Last Updated: November 2, 2024

Hydrocortisone acetate; pramoxine hydrochloride - Generic Drug Details


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What are the generic drug sources for hydrocortisone acetate; pramoxine hydrochloride and what is the scope of patent protection?

Hydrocortisone acetate; pramoxine hydrochloride is the generic ingredient in four branded drugs marketed by Mylan Speciality Lp, Genus, Sebela Ireland Ltd, and Ferndale Labs, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for hydrocortisone acetate; pramoxine hydrochloride
Pharmacology for hydrocortisone acetate; pramoxine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for hydrocortisone acetate; pramoxine hydrochloride
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs

US Patents and Regulatory Information for hydrocortisone acetate; pramoxine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 085979-001 Approved Prior to Jan 1, 1982 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genus HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1% hydrocortisone acetate; pramoxine hydrochloride AEROSOL, METERED;TOPICAL 089440-001 May 17, 1988 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ferndale Labs PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 083213-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sebela Ireland Ltd PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 085980-001 Approved Prior to Jan 1, 1982 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp PROCTOFOAM HC hydrocortisone acetate; pramoxine hydrochloride AEROSOL, METERED;TOPICAL 086195-001 Approved Prior to Jan 1, 1982 BX RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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