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g. AB1, AB2, AB7). Three-character codes are assigned only in circumstances when more than one reference mentioned drug of precisely the same toughness has been designated under the identical heading. Two or more reference listed medicines are typically selected only when there are actually at the least two probable reference drug products and solutions which aren't bioequivalent to one another. If a study is submitted that demonstrates bioequivalence to a certain listed drug merchandise, the generic product is going to be offered the identical a few-character code as the reference website outlined drug it had been in comparison against.
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Exclusivity is the only advertising rights granted from the FDA into a company on the approval of the drug and could run simultaneously using a patent. Exclusivity intervals can run from a hundred and eighty days to 7 a long time depending upon the circumstance of your exclusivity grant.
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