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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208419
Company: ACTAVIS

Products on NDA 208419

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEMETREXED	PEMETREXED	100MG/4ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
PEMETREXED	PEMETREXED	500MG/20ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
PEMETREXED	PEMETREXED	1GM/40ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208419

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/21/2020	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208419s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208419Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/208419Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2022	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208419Orig1s004ltr.pdf
11/22/2022	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208419Orig1s003ltr.pdf
11/22/2022	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208419Orig1s002ltr.pdf

Labels for NDA 208419

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2022	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s004lbl.pdf
11/22/2022	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s003lbl.pdf
11/22/2022	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s002lbl.pdf
08/21/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208419s000lbl.pdf

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