Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZENATANE | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | AB1 | No | No |
ZENATANE | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | AB1 | No | No |
ZENATANE | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | AB1 | No | No |
ZENATANE | 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 |
---|---|---|---|---|---|---|---|
03/25/2013 | ORIG-1 | Approval | Not Applicable |
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-33 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
10/06/2022 | SUPPL-31 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
08/04/2022 | SUPPL-29 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/23/2022 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
10/08/2021 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
11/09/2021 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
12/09/2020 | SUPPL-21 | REMS-Proposal, REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
11/16/2020 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2018 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
04/23/2018 | SUPPL-12 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
05/02/2018 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
06/17/2017 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
07/08/2016 | SUPPL-7 | REMS-Modified |
Label is not available on this site. |
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02/04/2016 | SUPPL-5 | REMS-Modified |
Label is not available on this site. |
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09/03/2015 | SUPPL-4 | REMS-Modified |
Label is not available on this site. |
||
02/23/2015 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels, REMS-Modified |
Label is not available on this site. |
ZENATANE
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 |