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Did you know? |
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FDA Requirements
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Brand |
Generic |
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FDA reviews data for reformulation of a drug or a generic version
showing it is bioequivalent to the original drug
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X |
X |
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FDA reviews tests of the drug’s active and inactive ingredients
before it is approved
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X |
X |
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FDA ensures the manufacturer meets required manufacturing practices before
the drug is marketed
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X |
X |
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FDA reviews tests of the actual drug product
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X |
X |
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FDA reviews the drug’s labeling
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X |
X |
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Manufacturer must seek FDA approval before Making manufacturing changes or
reformulating the drug
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X |
X |
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Manufacturer must report drug’s adverse reactions and adverse health
effects to FDA
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X |
X |
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FDA inspects manufacturing facilities
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X |
X |
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FDA monitors drug quality after approval
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X |
X |
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* Manufacturer must report drug's adverse reactions and adverse health effects to FDA for both generic and brand named drugs.
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ZENITH GOLDLINE PHARMACEUTICALS has been approved to sell a generic form of CECLOR CD in tablet, extended release form.
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Zyloprim
300MG (90Tablets)
Brand Name: $63.79
Generic:
$11.70
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