NEO-FRADIN; Neomycin Sulfate Oral Solution USP 60 mL (2 fl. oz)

VIAL LABEL - 60 mL (2fl. oz)

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60 mL(z II. oz.) 0

~!2-Fradi~Neomycin Sulfate Oral Solution 'Ø

USUAL DOSAGE: See package insert forcomplete product Information,

DIspense in tight, light-resistant containers.Store at controlled room temperature

15' to 3D' C (59' to 86' F)Each 5 mL (one teaspoonful) contains:

Neomycin Sulfate 125 mg(equivalent to 87.5 mg neomycin)

Contains FD & C Yellow NO.6(sunset yellow) as a color additive.

125 mg per 5 mL

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( NEO-FRADIN; Neomycin Sulfate Oral Solution USP 120 mL (4 fl. oz)

VIAL LABEL - 120 mL (4 fl. oz)

4 OZ NEO.FRADIN ORAL SOLUTION 45 x 225f ~ ~..,.i-=t-o=.",l"' i. . "_~''''''L''~ .y '\"#-;:~::':. ~""""-~'''-.7- '::':'l, .'ri..-~~.f_. f.P\; T'J . ...=_"'_..."' ~i, ." .-e...."._~:L~(;t 814697000, -" NDC 39822-0330-4. - ~tfl-A~'-""~' :...,....~_~ '~...".."",:.~~':_....h ".w.~...... ~ ,.'c"._~.._"'1- "'-""~,'7 _&"~'",.,_".--.~~_ ~~'"~.~."'_~. .;,;;

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_ 120 mL (4 II. OZ.) USUAL DOSAGE: See

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insert for complete~ ò product Information.¡:. Oral Solution Dispense In tight,c; ,,.. light-resIstant containers.

(' = ~.O Neomycin Sulfate Oral Solution USP Store at controlled room temperature

N - "'I 15't030'C(59't086'F):: ~. Each 5 mL (one teaspoonful)--. contains:-- z", Neomycin Sulfate 125 mg:: D (equivalent to 87.5 mg neomycin)Manufactured for: i.~ om ContaIns FD & C Yellow

c; Y NO.6 (sunset yellow) as aPharma.Tek, Inc. HunUngtoo 'LY, 11743-0568. . g:h r- p color additive._ Q)una~ 3 ',.

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r --) 1.Pharma-Tekleomycin Sulfate Oral Solution USP, 125 mg/5 mL Rev. NO.1ANDA 65-010

2 . ANDA # 65 - 010

3. NAME AND ADDRESS OF APPLICANTPharma-Tek Inc.P .0. Box 1920Huntington, NY11743-0568

Headguarters (assembly of submission)Pharma-Tek Inc.P.O. Box 1920Huntington, NY11743 - 0568

Attention: Susan E. BadiaTel. : 516-757-5522Fax: 5 1 6 - 754 - 155 0

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Distributor:Pharma-Tek Inc.744 Baldwin St.Elmira, NY 14901

Contact person: J. Robin Liles, Director of OperationsTel. : 607-732-5555Fax: 6 0 7 - 732 - 4 3 82

Manufacturing Facility:i

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4. LEGAL BASIS for ANDA SUBMISSION:Pharma-Tek has been distributing this product under privatelabel for the innovator firm under contract since 1996.Recently the innovator, Pharmacia-Upj ohn, discontinuedproduction and sale of the product. Pharma-Tek purchàsed theapplication and excess inventory from innovator and thisapplication is for drug product identical in formulation toinnovator N50-285.

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