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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214657
Company: SANDOZ

Products on NDA 214657

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 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214657

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/26/2022	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214657s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214657Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214657Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2025	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214657s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214657Orig1s006ltr.pdf
04/21/2023	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214657s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214657Orig1s003ltr.pdf

Labels for NDA 214657

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2025	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214657s006lbl.pdf
04/21/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214657s003lbl.pdf
05/26/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214657s000lbl.pdf

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