Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209365
Company: MSN LABS PVT LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription AB No No
CAPECITABINE CAPECITABINE 500MG 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
07/02/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

CAPECITABINE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 202593 ACCORD HLTHCARE
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 207652 ALKEM LABS LTD
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 204741 AMNEAL PHARMS
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 210604 EUGIA PHARMA
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 209365 MSN LABS PVT LTD
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 090943 MYLAN
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 207456 SHILPA MEDICARE LTD
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 204668 SUN PHARM
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 091649 TEVA PHARMS USA
CAPECITABINE CAPECITABINE 150MG TABLET;ORAL Prescription No AB 200483 WEST-WARD PHARMS INT
XELODA CAPECITABINE 150MG TABLET;ORAL Prescription Yes AB 020896 HOFFMANN LA ROCHE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 202593 ACCORD HLTHCARE
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 207652 ALKEM LABS LTD
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 204741 AMNEAL PHARMS
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 210604 EUGIA PHARMA
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 209365 MSN LABS PVT LTD
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 090943 MYLAN
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 207456 SHILPA MEDICARE LTD
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 204668 SUN PHARM
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 091649 TEVA PHARMS USA
CAPECITABINE CAPECITABINE 500MG TABLET;ORAL Prescription No AB 200483 WEST-WARD PHARMS INT
XELODA CAPECITABINE 500MG TABLET;ORAL Prescription Yes AB 020896 HOFFMANN LA ROCHE

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