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FDA Requirements
Brand Generic
* FDA reviews data for reformulation of a drug  or a generic version showing it is bioequivalent to the original drug
 X X
* FDA reviews tests of the drug’s active and inactive ingredients before it is approved
 X X
* FDA ensures the manufacturer meets required manufacturing practices before the drug is marketed
 X X
* FDA reviews tests of the actual drug product
X X
* FDA reviews the drug’s labeling
 X X
* Manufacturer must seek FDA approval before Making manufacturing changes or reformulating the drug
 X X
* Manufacturer must report drug’s adverse reactions and adverse health effects to FDA
 X X
* FDA inspects manufacturing facilities
X X
* FDA monitors drug quality after approval
 X X

 

* FDA inspects manufacturing facilities for both generic and brand named drug manufacturers.



MYLAN PHARMACEUTICALS INC has been approved to sell a generic form of BETAPACE in tablet form.



Tagamet
300MG (180Tablets)

Brand Name: $155.52
Generic: $38.88

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