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
CLOFARABINE از شرکت MYLAN LABS LTD
Abbreviated New Drug Application (ANDA): 208860
Company: MYLAN LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
11/06/2017 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/19/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
CLOFARABINE
SOLUTION;INTRAVENOUS; 20MG/20ML (1MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204029 | ABON PHARMS LLC |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212034 | ACCORD HLTHCARE |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208857 | AMNEAL |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205375 | DR REDDYS LABS LTD |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207831 | GLAND PHARMA LTD |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213461 | MEITHEAL |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209775 | MSN |
CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208860 | MYLAN LABS LTD |
CLOLAR | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 021673 | GENZYME |
منبع : www.accessdata.fda.gov
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