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
CLARAVIS از شرکت TEVA PHARMS USA
Abbreviated New Drug Application (ANDA): 076135
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARAVIS | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription |
AB1 |
No | Yes |
| CLARAVIS | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription |
AB1 |
No | No |
| CLARAVIS | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription |
AB1 |
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 |
|---|---|---|---|---|---|---|---|
| 04/11/2003 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/09/2020 | SUPPL-50 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 08/31/2018 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/23/2018 | SUPPL-42 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 05/02/2018 | SUPPL-41 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 06/17/2017 | SUPPL-38 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 07/08/2016 | SUPPL-37 | REMS-Modified |
Label is not available on this site. |
||
| 02/04/2016 | SUPPL-36 | REMS-Modified |
Label is not available on this site. |
||
| 09/03/2015 | SUPPL-35 | REMS-Proposal |
Label is not available on this site. |
||
| 07/20/2015 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2012 | SUPPL-29 | REMS-Proposal |
Label is not available on this site. |
||
| 10/22/2010 | SUPPL-18 | REMS-Proposal |
Label is not available on this site. |
||
| 03/25/2010 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/02/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/02/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/02/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/12/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/11/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
CLARAVIS
CAPSULE;ORAL; 40MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMNESTEEM | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB1 | 075945 | MYLAN PHARMS INC |
| CLARAVIS | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB1 | 076135 | TEVA PHARMS USA |
| ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB1 | 207792 | AMNEAL PHARMS NY |
| MYORISAN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB1 | 076485 | DOUGLAS PHARMS |
| ZENATANE | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB1 | 202099 | DR REDDYS LABS LTD |
CAPSULE;ORAL; 20MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMNESTEEM | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB1 | 075945 | MYLAN PHARMS INC |
| CLARAVIS | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB1 | 076135 | TEVA PHARMS USA |
| ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB1 | 207792 | AMNEAL PHARMS NY |
| MYORISAN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB1 | 076485 | DOUGLAS PHARMS |
| ZENATANE | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB1 | 202099 | DR REDDYS LABS LTD |
CAPSULE;ORAL; 30MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLARAVIS | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB1 | 076135 | TEVA PHARMS USA |
| ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB1 | 207792 | AMNEAL PHARMS NY |
| MYORISAN | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB1 | 076485 | DOUGLAS PHARMS |
| ZENATANE | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB1 | 202099 | DR REDDYS LABS LTD |
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