208910Orig1s000 - Food and Drug Administration
2018-8-8 · PREA do not apply to the proposed NDA. 1.8 Waiver of in vivo Bioavailability Studies . The Applicant requests a waiver from providing evidence of in vivo bioequivalence of Vancomycin Hydrochloride Powder for Oral Solution Kit relative to the reference drugs, Vancomycin Hydrochloride Capsules USP (NDA 050606) or Vancomycin Hydrochloride for
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