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Last Updated: November 2, 2024

Gramicidin; neomycin sulfate; polymyxin b sulfate - Generic Drug Details


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What are the generic sources for gramicidin; neomycin sulfate; polymyxin b sulfate and what is the scope of freedom to operate?

Gramicidin; neomycin sulfate; polymyxin b sulfate is the generic ingredient in four branded drugs marketed by Dow Pharm, Bausch And Lomb, Ipharm, Nordic Pharma, Watson Labs, Pharmafair, and Monarch Pharms, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for gramicidin; neomycin sulfate; polymyxin b sulfate
Recent Clinical Trials for gramicidin; neomycin sulfate; polymyxin b sulfate

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

SponsorPhase
Chulalongkorn UniversityPhase 3

See all gramicidin; neomycin sulfate; polymyxin b sulfate clinical trials

Pharmacology for gramicidin; neomycin sulfate; polymyxin b sulfate
Anatomical Therapeutic Chemical (ATC) Classes for gramicidin; neomycin sulfate; polymyxin b sulfate
A01AB Antiinfectives and antiseptics for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07AA Antibiotics
A07A INTESTINAL ANTIINFECTIVES
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
A07AA Antibiotics
A07A INTESTINAL ANTIINFECTIVES
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
B05CA Antiinfectives
B05C IRRIGATING SOLUTIONS
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
D06AX Other antibiotics for topical use
D06A ANTIBIOTICS FOR TOPICAL USE
D06 ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D Dermatologicals
J01GB Other aminoglycosides
J01G AMINOGLYCOSIDE ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
J01XB Polymyxins
J01X OTHER ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
R02AB Antibiotics
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
R02AB Antibiotics
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for gramicidin; neomycin sulfate; polymyxin b sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN gramicidin; neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 064047-001 Jan 31, 1996 AT RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharmafair NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN gramicidin; neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 062383-001 Aug 31, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Monarch Pharms NEOSPORIN gramicidin; neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 060582-001 Approved Prior to Jan 1, 1982 AT RX No 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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