An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 209472
Company: EAGLE PHARMS

Products on NDA 209472

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEMFEXY	PEMETREXED	500MG/20ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209472

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/08/2020	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209472s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209472Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209472Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/14/2022	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209472s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209472Orig1s005ltr.pdf
06/17/2020	SUPPL-1	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209472s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209472Orig1s001ltr.pdf

Labels for NDA 209472

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/14/2022	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209472s005lbl.pdf
06/17/2020	SUPPL-1	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209472s001lbl.pdf
02/08/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209472s000lbl.pdf

Top