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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214408
Company: ACCORD HLTHCARE

Products on NDA 214408

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214408

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/19/2022	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214408s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214408Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214408Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214408s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214408Orig1s003ltr.pdf

Labels for NDA 214408

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214408s003lbl.pdf
07/19/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214408s000lbl.pdf

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