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Abbreviated New Drug Application (ANDA): 209373
Company: AMNEAL PHARMS CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHYTONADIONE PHYTONADIONE 5MG 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
05/11/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209373Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2024 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

PHYTONADIONE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHYTONADIONE PHYTONADIONE 5MG TABLET;ORAL Prescription No AB 213336 AGNITIO
PHYTONADIONE PHYTONADIONE 5MG TABLET;ORAL Prescription No AB 209373 AMNEAL PHARMS CO
PHYTONADIONE PHYTONADIONE 5MG TABLET;ORAL Prescription No AB 213329 SCIEGEN PHARMS INC
PHYTONADIONE PHYTONADIONE 5MG TABLET;ORAL Prescription No AB 210189 ZYDUS LIFESCIENCES
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