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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208574
Company: TEVA PHARMS USA INC

Products on NDA 208574

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROMIDEPSIN	ROMIDEPSIN	10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
ROMIDEPSIN	ROMIDEPSIN	27.5MG/5.5ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208574

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/13/2020	ORIG-2	Approval	Efficacy	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574Orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208574Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/208574Orig1s000,Orig2s000TOC.cfm
03/13/2020	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208574Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/208574Orig1s000,Orig2s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2021	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208574s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208574Orig1s006ltr.pdf

Labels for NDA 208574

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208574s006lbl.pdf
03/13/2020	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574Orig2lbl.pdf
03/13/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574s000lbl.pdf

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