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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018667
Company: HOSPIRA

Products on NDA 018667

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 018667

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/1982	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/31/2022	SUPPL-43	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018667Orig1s043Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018667Orig1s043Corrected_ltr.pdf
09/22/2016	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018667s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018667Orig1s036ltr.pdf
05/10/2012	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
10/25/2002	SUPPL-19	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/22/2001	SUPPL-18	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/22/2001	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/07/2000	SUPPL-16	Labeling		Label is not available on this site.
01/07/2000	SUPPL-15	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/12/1997	SUPPL-14	Labeling		Label is not available on this site.
10/03/1996	SUPPL-13	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
01/27/1994	SUPPL-9	Labeling		Label is not available on this site.
03/09/1993	SUPPL-8	Labeling		Label is not available on this site.
07/09/1992	SUPPL-7	Labeling		Label is not available on this site.
06/16/1988	SUPPL-6	Labeling		Label is not available on this site.
01/20/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/20/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/20/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018667

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/31/2022	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018667Orig1s043Corrected_lbl.pdf
09/22/2016	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018667s036lbl.pdf

Therapeutic Equivalents for NDA 018667

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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