Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211226
Company: ACROTECH BIOPHARMA

Products on NDA 211226

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	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211226

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; Orphan	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

Labels for NDA 211226

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