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    POLYMYCIN B SULFATE

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    01 1XELLIA PHARMS APS

    02 2ALLERGAN

    03 3ALCON

    04 1ALCON PHARMS LTD

    05 1ALTANA

    06 2AMNEAL

    07 9BAUSCH AND LOMB

    08 4CASPER PHARMA LLC

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    11 1EPIC PHARMA LLC

    12 1EUGIA PHARMA

    13 1FOREST LABS

    14 1FRESENIUS KABI USA

    15 1GLAND

    16 3GLAXOSMITHKLINE

    17 1HARROW EYE

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    20 9MONARCH PHARMS

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    22 2NOVARTIS

    23 4PADAGIS US

    24 1PADDOCK LLC

    25 1PARKE DAVIS

    26 1PARKEDALE

    27 2PFIZER

    28 1PHARMACIA AND UPJOHN

    29 1PHARMADERM

    30 11PHARMAFAIR

    31 1PHARMOBEDIENT

    32 1RISING

    33 6SANDOZ

    34 1SAPTALIS PHARMS

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    36 5SCIEGEN PHARMS

    37 1SOMERSET THERAPS LLC

    38 4WATSON LABS

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    01

    XELLIA PHARMS APS

    Denmark
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    CPhI Milan
    Booth #18A31
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    Virtual BoothXellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.

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    RLD : No

    TE Code : AP

    POLYMYXIN B SULFATE

    Brand Name : POLYMYXIN B SULFATE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 500,000 UNITS BASE/VIAL

    Approval Date : 2014-01-15

    Application Number : 202766

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    02

    ALLERGAN

    U.S.A
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    PEGS Boston Summit
    Not Confirmed
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    RLD : No

    TE Code :

    NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

    Brand Name : POLY-PRED

    Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

    Dosage Strength : EQ 0.35% BASE;10,000 UNITS/ML;0.5%

    Approval Date : 1982-01-01

    Application Number : 50081

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Abbvie CB

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    03

    ALLERGAN

    U.S.A
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    PEGS Boston Summit
    Not Confirmed
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    RLD : Yes

    TE Code :

    POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

    Brand Name : POLYTRIM

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

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

    Approval Date : 1988-10-20

    Application Number : 50567

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

    Abbvie CB

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    04

    GLAXOSMITHKLINE

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    GLAXOSMITHKLINE

    United Kingdom
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    RLD : No

    TE Code :

    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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    05

    GLAXOSMITHKLINE

    United Kingdom
    PEGS Boston Summit
    Not Confirmed
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    GLAXOSMITHKLINE

    United Kingdom
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    PEGS Boston Summit
    Not Confirmed
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    RLD : No

    TE Code :

    NEOMYCIN SULFATE; POLYMYXIN B SULFATE

    Brand Name : NEOSPORIN

    Dosage Form : CREAM;TOPICAL

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

    Approval Date : 1985-01-14

    Application Number : 50176

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    06

    HARROW EYE

    U.S.A
    PEGS Boston Summit
    Not Confirmed
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    HARROW EYE

    U.S.A
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    Not Confirmed
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    RLD : Yes

    TE Code : AT

    DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

    Brand Name : MAXITROL

    Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

    Dosage Strength : 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

    Approval Date : 1982-01-01

    Application Number : 50023

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AT

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    07

    MONARCH PHARMS

    U.S.A
    PEGS Boston Summit
    Not Confirmed
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    MONARCH PHARMS

    U.S.A
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    Not Confirmed
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    RLD : Yes

    TE Code :

    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 :

    blank

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    08

    MONARCH PHARMS

    U.S.A
    PEGS Boston Summit
    Not Confirmed
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    MONARCH PHARMS

    U.S.A
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    PEGS Boston Summit
    Not Confirmed
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    RLD : No

    TE Code :

    HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

    Brand Name : CORTISPORIN

    Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

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

    Approval Date : 1982-01-01

    Application Number : 50169

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    09

    PARKEDALE

    U.S.A
    PEGS Boston Summit
    Not Confirmed
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    PARKEDALE

    U.S.A
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    PEGS Boston Summit
    Not Confirmed
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    RLD : No

    TE Code :

    CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE

    Brand Name : OPHTHOCORT

    Dosage Form : OINTMENT;OPHTHALMIC

    Dosage Strength : 10MG/GM;5MG/GM;10,000 UNITS/GM

    Approval Date : 1982-01-01

    Application Number : 50201

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    blank

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    10

    SANDOZ

    Switzerland
    PEGS Boston Summit
    Not Confirmed
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    SANDOZ

    Switzerland
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    Not Confirmed
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    RLD : Yes

    TE Code : AT

    DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

    Brand Name : MAXITROL

    Dosage Form : OINTMENT;OPHTHALMIC

    Dosage Strength : 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

    Approval Date : 1982-01-01

    Application Number : 50065

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AT

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