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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 211109Orig1s000 Trade Name:KERALA injection, 50 mg per vialGeneric or Established:eravacyclineSponsor:Tetra phase
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wwwaccessdatafdagov drugsatfdadocs nda207924orig1s000 is the original application submitted to the FDA for a new drug approval.
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