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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018267
Company: HIKMA

Products on NDA 018267

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 018267

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/1981	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
10/01/2024	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018267s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018267Orig1s029ltr.pdf
05/10/2023	SUPPL-27	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018267s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018267Orig1s027ltr.pdf
08/29/2001	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/2001	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
09/03/1999	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
03/02/1999	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
08/08/1997	SUPPL-21	Labeling		Label is not available on this site.
11/18/1993	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/21/1992	SUPPL-18	Labeling		Label is not available on this site.
02/05/1992	SUPPL-17	Labeling		Label is not available on this site.
02/05/1992	SUPPL-16	Labeling		Label is not available on this site.
10/17/1991	SUPPL-15	Labeling		Label is not available on this site.
11/14/1990	SUPPL-14	Labeling		Label is not available on this site.
11/03/1986	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/02/1985	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/12/1984	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/12/1984	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018267

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/01/2024	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018267s029lbl.pdf
05/10/2023	SUPPL-27	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018267s027lbl.pdf

Therapeutic Equivalents for NDA 018267

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	077941	APOTEX
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208435	AREVA PHARMS
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217557	ASPIRO
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
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	018267	HIKMA
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	218188	MICRO LABS
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215856	SABA ILAC SANAYIVE
FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214766	SAGENT

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