Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075405
Company: HIKMA

Products on ANDA 075405

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLADRIBINE	CLADRIBINE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075405

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2000	ORIG-1	Approval			Letter (PDF) Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75405ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75405ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075405_cladribine_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/08/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/07/2007	SUPPL-6	Labeling		Label is not available on this site.
04/03/2001	SUPPL-3	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
11/03/2000	SUPPL-2	Labeling		Label is not available on this site.
11/03/2000	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Therapeutic Equivalents for ANDA 075405

CLADRIBINE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLADRIBINE	CLADRIBINE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076571	FRESENIUS KABI USA
CLADRIBINE	CLADRIBINE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075405	HIKMA
CLADRIBINE	CLADRIBINE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210856	HISUN PHARM HANGZHOU