Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206254
Company: FRESENIUS KABI USA

Products on ANDA 206254

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROMIDEPSIN	ROMIDEPSIN	10MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206254

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206254Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 206254

ROMIDEPSIN

POWDER;INTRAVENOUS; 10MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISTODAX	ROMIDEPSIN	10MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	022393	BRISTOL-MYERS
ROMIDEPSIN	ROMIDEPSIN	10MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	206254	FRESENIUS KABI USA