اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CLADRIBINE از شرکت WEST-WARD PHARMS INT
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 |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75405ta.pdf |
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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