Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076485
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYORISAN | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | AB1 | No | No |
| MYORISAN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | AB1 | No | No |
| MYORISAN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | AB1 | No | No |
| MYORISAN | 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 |
|---|---|---|---|---|---|---|---|
| 01/19/2012 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/076485Orig1s003.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/16/2024 | SUPPL-39 | Labeling-Container/Carton Labels, Labeling-Proprietary Name Change |
Label is not available on this site. |
||
| 06/23/2023 | SUPPL-38 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/16/2024 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2022 | SUPPL-33 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/24/2022 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2021 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2021 | SUPPL-27 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/09/2020 | SUPPL-25 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/31/2018 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/23/2018 | SUPPL-19 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/02/2018 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/17/2017 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/08/2016 | SUPPL-13 | REMS-Modified |
Label is not available on this site. |
||
| 02/04/2016 | SUPPL-12 | REMS-Modified |
Label is not available on this site. |
||
| 09/03/2015 | SUPPL-10 | REMS-Modified |
Label is not available on this site. |
||
| 12/13/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2012 | SUPPL-3 | REMS-Modified |
Label is not available on this site. |
MYORISAN
CAPSULE;ORAL; 10MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMNESTEEM | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB1 | 075945 | MYLAN PHARMS INC |
| CLARAVIS | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB1 | 076356 | TEVA PHARMS USA |
| ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB1 | 207792 | AMNEAL PHARMS NY |
| ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB1 | 211568 | ZYDUS PHARMS |
| MYORISAN | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB1 | 076485 | UPSHER SMITH LABS |
| ZENATANE | ISOTRETINOIN | 10MG | 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; 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; 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 |