Drugs@FDA: FDA-Approved Drugs
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 |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-60 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/06/2022 | SUPPL-58 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 03/04/2024 | SUPPL-56 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/23/2022 | SUPPL-55 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2021 | SUPPL-53 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/08/2021 | SUPPL-52 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 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 |
| ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB1 | 211568 | ZYDUS PHARMS |
| MYORISAN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB1 | 076485 | UPSHER SMITH LABS |
| 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 |
| ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB1 | 211568 | ZYDUS PHARMS |
| MYORISAN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB1 | 076485 | UPSHER SMITH LABS |
| 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 |
| ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB1 | 211568 | ZYDUS PHARMS |
| MYORISAN | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB1 | 076485 | UPSHER SMITH LABS |
| ZENATANE | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB1 | 202099 | DR REDDYS LABS LTD |