Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208746
Company: HOSPIRA

Products on NDA 208746

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEMETREXED DITROMETHAMINE	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	TBD	Yes	Yes
PEMETREXED DITROMETHAMINE	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	TBD	Yes	Yes
PEMETREXED DITROMETHAMINE	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208746

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2022	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208746s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208746Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/208746Orig1s000TOC.cfm

Labels for NDA 208746

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208746s000lbl.pdf

Therapeutic Equivalents for NDA 208746

PEMETREXED DITROMETHAMINE

There are no Therapeutic Equivalents.