Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210661
Company: APOTEX INC

Products on NDA 210661

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEMETREXED	PEMETREXED	100MG	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No
PEMETREXED	PEMETREXED	500MG	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210661

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2018	ORIG-1	Tentative Approval	Type 2 - New Active Ingredient	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210661Orig1s000TAltr.pdf