Drugs@FDA: FDA-Approved Drugs
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMNESTEEM | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | AB1 | No | No |
| AMNESTEEM | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | AB1 | No | No |
| AMNESTEEM | ISOTRETINOIN | 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/08/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75945ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-46 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/06/2022 | SUPPL-44 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/23/2022 | SUPPL-43 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/08/2021 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2021 | SUPPL-40 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/09/2020 | SUPPL-39 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/31/2018 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/23/2018 | SUPPL-36 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/02/2018 | SUPPL-35 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/17/2017 | SUPPL-34 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/08/2016 | SUPPL-33 | REMS-Modified |
Label is not available on this site. |
||
| 02/04/2016 | SUPPL-32 | REMS-Modified |
Label is not available on this site. |
||
| 09/03/2015 | SUPPL-31 | REMS-Modified, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2015 | SUPPL-28 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2012 | SUPPL-26 | REMS-Modified |
Label is not available on this site. |
||
| 04/12/2012 | SUPPL-25 | REMS |
Label is not available on this site. |
||
| 04/12/2012 | SUPPL-22 | REMS-Modified |
Label is not available on this site. |
||
| 04/12/2012 | SUPPL-17 | REMS-Modified |
Label is not available on this site. |
||
| 04/12/2012 | SUPPL-16 | REMS-Modified |
Label is not available on this site. |
||
| 10/22/2010 | SUPPL-15 | REMS-Proposal |
Label is not available on this site. |
||
| 03/25/2010 | SUPPL-14 | Labeling-Package Insert |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/075945Orig1s014.pdf |
| 11/02/2007 | SUPPL-11 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/075945Orig1s011.pdf |
| 02/06/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/12/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/25/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/25/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/27/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
AMNESTEEM
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 |