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
CLOLAR از شرکت GENZYME
New Drug Application (NDA): 021673
Company: GENZYME
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOLAR | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
AP |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/28/2004 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021673lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2019 | SUPPL-26 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021673s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021673Orig1s026ltr.pdf |
||
| 10/27/2016 | SUPPL-25 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021673s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021673Orig1s025ltr.pdf |
||
| 12/16/2015 | SUPPL-24 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021673s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021673Orig1s024ltr.pdf |
||
| 09/15/2014 | SUPPL-23 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021673s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021673Orig1s023ltr.pdf |
||
| 01/10/2013 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021673s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021673Orig1s022ltr.pdf |
||
| 06/10/2011 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021673s010lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021673s010ltr.pdf |
||
| 10/17/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021673s005,s007ltr.pdf |
|
| 10/17/2008 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021673s005,s007ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/20/2019 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021673s026lbl.pdf | |
| 10/27/2016 | SUPPL-25 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021673s025lbl.pdf | |
| 12/16/2015 | SUPPL-24 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021673s024lbl.pdf | |
| 09/15/2014 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021673s023lbl.pdf | |
| 01/10/2013 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021673s022lbl.pdf | |
| 06/10/2011 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021673s010lbledt.pdf | |
| 12/28/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021673lbl.pdf |
CLOLAR
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 |
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