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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212501
Company: DR REDDYS

Products on NDA 212501

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212501

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2020	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212501s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212501Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/212501Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2025	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212501s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212501Orig1s007ltr.pdf
11/19/2021	SUPPL-3	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212501Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212501Orig1s003ltr.pdf
09/09/2021	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212501s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212501Orig1s002ltr.pdf

Labels for NDA 212501

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2025	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212501s007lbl.pdf
11/19/2021	SUPPL-3	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212501Orig1s003lbl.pdf
09/09/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212501s002lbl.pdf
09/09/2021	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212501s002lbl.pdf
07/30/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212501s000lbl.pdf

Therapeutic Equivalents for NDA 212501

CYCLOPHOSPHAMIDE

SOLUTION;INTRAVENOUS; 500MG/2.5ML (200MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	212501	DR REDDYS
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216783	NEXUS

SOLUTION;INTRAVENOUS; 1GM/5ML (200MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	212501	DR REDDYS
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216783	NEXUS

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