Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075405
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLADRIBINE CLADRIBINE 1MG/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
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/1999/75405ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75405ltr.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.

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 210856 HISUN PHARM HANGZHOU
CLADRIBINE CLADRIBINE 1MG/ML INJECTABLE;INJECTION Prescription No AP 200510 MYLAN LABS LTD
CLADRIBINE CLADRIBINE 1MG/ML INJECTABLE;INJECTION Prescription No AP 075405 WEST-WARD PHARMS INT

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