Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075405
Company: HIKMA
Company: HIKMA
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 | 075405 | HIKMA |
CLADRIBINE | CLADRIBINE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210856 | HISUN PHARM HANGZHOU |