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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212918
Company: BIONPHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/30/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

ATOVAQUONE

SUSPENSION;ORAL; 750MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription No AB 210510 ABHAI LLC
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription No AB 214272 ABON PHARMS LLC
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription No AB 202960 AMNEAL PHARMS
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription No AB 209750 APOTEX
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription No AB 212918 BIONPHARMA INC
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription No AB 207833 CHARTWELL RX
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription No AB 209685 GLENMARK PHARMS
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription No AB 210692 HETERO LABS LTD III
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription No AB 209105 LUPIN LTD
MEPRON ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription Yes AB 020500 GLAXOSMITHKLINE LLC
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