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Doses and ingredients could be different to whats on the label, and theres risk of contamination
"AAMs members recommend that the Agency clarify now how applicants with antibiotic drug products that are currently under development for approval under abbreviated new drug applications (ANDAs) should establish specifications for impurities during the period before the guidance is finalized," said the group
[PMID: 8938464] PubMed record related to this compound for laboratory literature review
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