Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075241
Company: HOSPIRA

Products on ANDA 075241

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 ANDA 075241

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-241_Furosemide_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75241ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-241_Furosemide.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2022	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/05/2022	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
05/10/2012	SUPPL-12	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 075241

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-241_Furosemide_prntlbl.pdf

Therapeutic Equivalents for ANDA 075241

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