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Approved Drug Products containing NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE listed in the FDA Orange Book. Original Data : FDA Website

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01 1ALTANA

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03 3BAUSCH AND LOMB

04 2CASPER PHARMA LLC

05 3COMBE

06 1DOW PHARM

07 1GLAXOSMITHKLINE

08 1LILLY

09 2MONARCH PHARMS

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11 4PADAGIS US

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16 2QUAD PHARMS

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18 2X GEN PHARMS

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PharmaCompass

01

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BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Brand Name : BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date : 1982-01-01

Application Number : 60731

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

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BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Brand Name : NEO-POLYCIN

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date : 1982-01-01

Application Number : 60647

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

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BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Brand Name : CORTISPORIN

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 50416

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

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BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Brand Name : LUMI-SPORYN

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM

Approval Date : 1982-01-01

Application Number : 50417

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AT

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05

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BACITRACIN

Brand Name : BACITRACIN

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 500 UNITS/GM

Approval Date : 1982-01-01

Application Number : 60687

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

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BACITRACIN ZINC; POLYMYXIN B SULFATE

Brand Name : POLYSPORIN

Dosage Form : AEROSOL;TOPICAL

Dosage Strength : 10,000 UNITS/GM;2,000,000 UNITS/GM

Approval Date : 1985-03-01

Application Number : 50167

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

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BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Brand Name : NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date : 1982-01-01

Application Number : 60764

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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08

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BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Brand Name : CORTISPORIN

Dosage Form : OINTMENT;TOPICAL

Dosage Strength : 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-05-04

Application Number : 50168

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

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BACITRACIN

Brand Name : BACIGUENT

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 500 UNITS/GM

Approval Date : 1982-01-01

Application Number : 60734

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

COMBE

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COMBE

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BACITRACIN; POLYMYXIN B SULFATE

Brand Name : LANABIOTIC

Dosage Form : DISC;TOPICAL

Dosage Strength : 500 UNITS/GM;5,000 UNITS/GM

Approval Date : 1986-09-22

Application Number : 50598

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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