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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210123
Company: GLAND

Products on ANDA 210123

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOROURACIL	FLUOROURACIL	500MG/10ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
FLUOROURACIL	FLUOROURACIL	1GM/20ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210123

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2017	ORIG-1	Approval		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
11/12/2025	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210123Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210123Orig1s011,210124Orig1s012ltr.pdf
03/21/2024	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210123s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210123Orig1s008;210124Orig1s009ltr.pdf
09/14/2022	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Labels for ANDA 210123

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/12/2025	SUPPL-11	Tentative Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210123Orig1s011lbl.pdf
03/21/2024	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210123s008lbl.pdf

Therapeutic Equivalents for ANDA 210123

FLUOROURACIL

INJECTABLE;INJECTION; 500MG/10ML (50MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOROURACIL	FLUOROURACIL	500MG/10ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	040743	ACCORD HLTHCARE
FLUOROURACIL	FLUOROURACIL	500MG/10ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	202668	EUGIA PHARMA SPECLTS
FLUOROURACIL	FLUOROURACIL	500MG/10ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	040279	FRESENIUS KABI USA
FLUOROURACIL	FLUOROURACIL	500MG/10ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210123	GLAND
FLUOROURACIL	FLUOROURACIL	500MG/10ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203608	SAGENT PHARMS INC

INJECTABLE;INJECTION; 1GM/20ML (50MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOROURACIL	FLUOROURACIL	1GM/20ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	040743	ACCORD HLTHCARE
FLUOROURACIL	FLUOROURACIL	1GM/20ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	202668	EUGIA PHARMA SPECLTS
FLUOROURACIL	FLUOROURACIL	1GM/20ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	040279	FRESENIUS KABI USA
FLUOROURACIL	FLUOROURACIL	1GM/20ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210123	GLAND
FLUOROURACIL	FLUOROURACIL	1GM/20ML (50MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203608	SAGENT PHARMS INC

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