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Abbreviated New Drug Application (ANDA): 203007
Company: NATCO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAPATINIB DITOSYLATE LAPATINIB DITOSYLATE EQ 250MG BASE TABLET;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
09/29/2020 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203007Orig1s000ltr.pdf

LAPATINIB DITOSYLATE

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAPATINIB DITOSYLATE LAPATINIB DITOSYLATE EQ 250MG BASE TABLET;ORAL Prescription No AB 203007 NATCO PHARMA LTD
TYKERB LAPATINIB DITOSYLATE EQ 250MG BASE TABLET;ORAL Prescription Yes AB 022059 NOVARTIS
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