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04:16 Jun 22, 2006 |
English language (monolingual) [PRO] Medical - Medical: Pharmaceuticals / Contact Lens Care Product | |||||||
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| Selected response from: Lingo Pros United States Local time: 01:34 | ||||||
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SUMMARY OF ALL EXPLANATIONS PROVIDED | ||||
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1 | A registeration number for the filled lot/ lot to be filled |
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fill lot # X A registeration number for the filled lot/ lot to be filled Explanation: COMPLETE: A proprietary multi-purpose solution (by Allergan) for all soft contact lenses which has a built-in lubricant to help provide more comfortable lens wear. COMPLETE is also the fastest growing multi-purpose solution in the world, growing at a rate of nearly 3:1 over the competition. Complete Upgrade C is an upgrade of the solution: http://www.shareholder.com/AGN/downloads/2001AnnualReport.pd... "Fill lot #" : (lot here means a parcel of articles offered as one item) It's the registeration number of a "set number of units" of the prodoct in the stage in which the product shipment was "filled". FDA: The licensed manufacturer shall submit information about the quantity of the product distributed under the product license, including the quantity distributed to distributors. The interval between distribution reports shall be 6 months. Upon written notice, FDA may require that the licensed manufacturer submit distribution reports under this section at times other than every 6 months. The distribution report shall consist of the bulk lot number (from which the final container was filled), the fill lot numbers for the total number of dosage units of each strength or potency distributed (e.g., fifty thousand per 10-milliliter vials), the label lot number (if different from fill lot number), labeled date of expiration, number of doses in fill lot/label lot, date of release of fill lot/label lot for distribution at that time. If any significant amount of a fill lot/ label lot is returned, include this information. http://google2.fda.gov/search?output=xml_no_dtd&oe=&lr=&prox... http://www.fda.gov/foi/warning_letters/g4238d.htm |
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