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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209389
Company: IPCA LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;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
10/30/2023 ORIG-1 Approval STANDARD

Label is not available on this site.

ONDANSETRON

TABLET, ORALLY DISINTEGRATING;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090469 AUROBINDO PHARMA
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077406 CHARTWELL MOLECULES
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078152 GLENMARK PHARMS LTD
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 209389 IPCA LABS LTD
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078050 SANDOZ
ONDANSETRON ONDANSETRON 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077557 SUN PHARM INDS

TABLET, ORALLY DISINTEGRATING;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090469 AUROBINDO PHARMA
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077406 CHARTWELL MOLECULES
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078152 GLENMARK PHARMS LTD
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 209389 IPCA LABS LTD
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078050 SANDOZ
ONDANSETRON ONDANSETRON 8MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077557 SUN PHARM INDS
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