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Abbreviated New Drug Application (ANDA): 210434
Company: CIPLA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBENDAZOLE ALBENDAZOLE 200MG 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
09/21/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210434Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/24/2020 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

ALBENDAZOLE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 208094 ACTAVIS ELIZABETH
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 210434 CIPLA LTD
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 211034 DR REDDYS
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 211117 EDENBRIDGE PHARMS
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 213435 MSN
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 210011 STRIDES PHARMA
ALBENDAZOLE ALBENDAZOLE 200MG TABLET;ORAL Prescription No AB 208979 ZYDUS PHARMS
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