U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 211226
Company: ACROTECH BIOPHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KHAPZORY LEVOLEUCOVORIN 175MG/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes
KHAPZORY LEVOLEUCOVORIN 300MG/VIAL POWDER;INTRAVENOUS Prescription None Yes 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
10/19/2018 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211226s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211226Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211226Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/03/2020 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211226s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211226Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/03/2020 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211226s002lbl.pdf
10/19/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211226s000lbl.pdf
Back to Top