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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018267
Company: HIKMA

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

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
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.

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

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 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 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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