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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018902
Company: FRESENIUS KABI USA

Products on NDA 018902

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018902

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/1984	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2023	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018902s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018902Orig1s035ltr.pdf
04/12/2022	SUPPL-33	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018902Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018902Orig1s033ltr.pdf
09/19/2016	SUPPL-28	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available. Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018902Orig1s028ltr.pdf
03/08/2016	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018902s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018902Orig1s027ltr.pdf
07/01/2015	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
03/27/2012	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
01/02/2001	SUPPL-16	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
01/11/1999	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/15/1997	SUPPL-14	Labeling		Label is not available on this site.
08/08/1997	SUPPL-13	Labeling		Label is not available on this site.
04/22/1997	SUPPL-12	Labeling		Label is not available on this site.
08/10/1995	SUPPL-11	Labeling		Label is not available on this site.
08/10/1995	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/16/1990	SUPPL-8	Labeling		Label is not available on this site.
04/18/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/11/1990	SUPPL-6	Labeling		Label is not available on this site.
08/10/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/16/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/05/1985	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018902

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2023	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018902s035lbl.pdf
04/12/2022	SUPPL-33	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018902Orig1s033lbl.pdf
04/12/2022	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018902Orig1s033lbl.pdf
03/08/2016	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018902s027lbl.pdf

Therapeutic Equivalents for NDA 018902

FUROSEMIDE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	070017	ACCORD HLTHCARE
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207552	AMNEAL PHARMS CO
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208435	AREVA PHARMS
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	203428	AVET LIFESCIENCES
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	202747	BAXTER HLTHCARE CORP
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212174	EUGIA PHARMA
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	018902	FRESENIUS KABI USA
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	213902	GLAND PHARMA LTD
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	018667	HOSPIRA
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075241	HOSPIRA
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216860	MANKIND PHARMA
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212803	MEITHEAL
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215856	SABA ILAC SANAYIVE
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214766	SAGENT
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077941	WOCKHARDT

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