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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208979
Company: ZYDUS PHARMS
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
12/14/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/2020 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

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 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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