Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021951
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABSORICA | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | AB2 | Yes | No |
| ABSORICA | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | AB2 | Yes | No |
| ABSORICA | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | AB2 | Yes | No |
| ABSORICA | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | AB2 | Yes | Yes |
| ABSORICA | ISOTRETINOIN | 25MG | CAPSULE;ORAL | Prescription | AB2 | Yes | No |
| ABSORICA | ISOTRETINOIN | 35MG | CAPSULE;ORAL | Prescription | AB2 | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/25/2012 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021951s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021951s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021951_absorica_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021951s024,211913s011lbl.pdf | |
| 07/18/2023 | SUPPL-23 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021951Orig1s024;211913Orig1s011ltr.pdf |
| 03/24/2023 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021951Orig1s022,211913Orig1s010ltr.pdf |
| 10/06/2022 | SUPPL-21 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021951Orig1s021ltr.pdf |
| 10/08/2021 | SUPPL-18 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021951Orig1s018ltr.pdf |
| 12/09/2020 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021951Orig1s017replacementltr.pdf |
| 01/24/2020 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021951Orig1s015ltr.pdf |
| 08/31/2018 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021951Orig1s014ltr.pdf | |
| 11/07/2019 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021951s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021951Orig1s013ltr.pdf | |
| 04/23/2018 | SUPPL-12 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021951Orig1s012ltr.pdf |
| 05/02/2018 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021951Orig1s011ltr.pdf | |
| 06/17/2017 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021951Orig1s010ltr.pdf |
| 07/08/2016 | SUPPL-8 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021951Orig1s008ltr.pdf |
| 02/04/2016 | SUPPL-7 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021951Orig1s007ltr.pdf |
| 12/23/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/2015 | SUPPL-5 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021951s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021951Orig1s005ltr.pdf | |
| 10/20/2014 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/2014 | SUPPL-3 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021951Orig1s003ltr.pdf | |
| 07/30/2014 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021951Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021951s024,211913s011lbl.pdf | |
| 11/07/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021951s013lbl.pdf | |
| 08/31/2018 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s014lbl.pdf | |
| 08/31/2018 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s014lbl.pdf | |
| 05/02/2018 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s011lbl.pdf | |
| 05/02/2018 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s011lbl.pdf | |
| 09/03/2015 | SUPPL-5 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021951s005lbl.pdf | |
| 08/15/2014 | SUPPL-3 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s003lbl.pdf |
| 07/30/2014 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s001lbl.pdf | |
| 05/25/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021951s000lbl.pdf |
ABSORICA
CAPSULE;ORAL; 10MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABSORICA | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | Yes | AB2 | 021951 | SUN PHARM INDS INC |
| ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB2 | 205063 | ACTAVIS LABS FL |
| ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |
| ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB2 | 212333 | UPSHER SMITH LABS |
CAPSULE;ORAL; 20MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABSORICA | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | Yes | AB2 | 021951 | SUN PHARM INDS INC |
| ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB2 | 205063 | ACTAVIS LABS FL |
| ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |
| ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB2 | 212333 | UPSHER SMITH LABS |
CAPSULE;ORAL; 30MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABSORICA | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | Yes | AB2 | 021951 | SUN PHARM INDS INC |
| ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB2 | 205063 | ACTAVIS LABS FL |
| ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |
| ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB2 | 212333 | UPSHER SMITH LABS |
CAPSULE;ORAL; 40MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABSORICA | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | Yes | AB2 | 021951 | SUN PHARM INDS INC |
| ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB2 | 205063 | ACTAVIS LABS FL |
| ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |
| ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB2 | 213571 | UPSHER SMITH LABS |
CAPSULE;ORAL; 25MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABSORICA | ISOTRETINOIN | 25MG | CAPSULE;ORAL | Prescription | Yes | AB2 | 021951 | SUN PHARM INDS INC |
| ISOTRETINOIN | ISOTRETINOIN | 25MG | CAPSULE;ORAL | Prescription | No | AB2 | 205063 | ACTAVIS LABS FL |
| ISOTRETINOIN | ISOTRETINOIN | 25MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |
CAPSULE;ORAL; 35MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABSORICA | ISOTRETINOIN | 35MG | CAPSULE;ORAL | Prescription | Yes | AB2 | 021951 | SUN PHARM INDS INC |
| ISOTRETINOIN | ISOTRETINOIN | 35MG | CAPSULE;ORAL | Prescription | No | AB2 | 205063 | ACTAVIS LABS FL |
| ISOTRETINOIN | ISOTRETINOIN | 35MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |