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Last Updated: September 21, 2021

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Chloramphenicol; prednisolone - Generic Drug Details

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What are the generic sources for chloramphenicol; prednisolone and what is the scope of patent protection?

Chloramphenicol; prednisolone is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for chloramphenicol; prednisolone.

Summary for chloramphenicol; prednisolone
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 14
Clinical Trials: 1
DailyMed Link:chloramphenicol; prednisolone at DailyMed
Recent Clinical Trials for chloramphenicol; prednisolone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all chloramphenicol; prednisolone clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for chloramphenicol; prednisolone
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
D06AX Other antibiotics for topical use
D06A ANTIBIOTICS FOR TOPICAL USE
D06 ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D Dermatologicals
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
D10AF Antiinfectives for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE PREPARATIONS
D Dermatologicals
G01AA Antibiotics
G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01 GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G Genito-urinary system and sex hormones
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
J01BA Amphenicols
J01B AMPHENICOLS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01AA Antibiotics
S01A ANTIINFECTIVES
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
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for chloramphenicol; prednisolone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan CHLOROPTIC-P S.O.P. chloramphenicol; prednisolone OINTMENT;OPHTHALMIC 061188-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Harvard Business School
Dow
McKesson
Colorcon

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