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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214596
Company: CIPLA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHYTONADIONE PHYTONADIONE 1MG/0.5ML INJECTABLE;INJECTION Prescription None No Yes
PHYTONADIONE PHYTONADIONE 10MG/ML INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/22/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214596Orig1s000ltr.pdf

PHYTONADIONE

There are no Therapeutic Equivalents.

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