Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216097
Company: AMNEAL PHARMS NY
Company: AMNEAL PHARMS NY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | AB2 | No | No |
| ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | AB2 | No | No |
| ISOTRETINOIN | ISOTRETINOIN | 25MG | CAPSULE;ORAL | Prescription | AB2 | No | No |
| ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | AB2 | No | No |
| ISOTRETINOIN | ISOTRETINOIN | 35MG | CAPSULE;ORAL | Prescription | AB2 | No | No |
| ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | AB2 | 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 |
|---|---|---|---|---|---|---|---|
| 10/07/2025 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/09/2026 | SUPPL-1 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
ISOTRETINOIN
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 | 216097 | AMNEAL PHARMS NY |
| ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |
| ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB2 | 212333 | UPSHER SMITH LABS |
| ISOTRETINOIN | ISOTRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB2 | 216633 | ZYDUS PHARMS |
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 | 216097 | AMNEAL PHARMS NY |
| ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |
| ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB2 | 212333 | UPSHER SMITH LABS |
| ISOTRETINOIN | ISOTRETINOIN | 20MG | CAPSULE;ORAL | Prescription | No | AB2 | 216633 | ZYDUS PHARMS |
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 | 216097 | AMNEAL PHARMS NY |
| ISOTRETINOIN | ISOTRETINOIN | 25MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |
| ISOTRETINOIN | ISOTRETINOIN | 25MG | CAPSULE;ORAL | Prescription | No | AB2 | 216633 | ZYDUS PHARMS |
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 | 216097 | AMNEAL PHARMS NY |
| ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |
| ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB2 | 212333 | UPSHER SMITH LABS |
| ISOTRETINOIN | ISOTRETINOIN | 30MG | CAPSULE;ORAL | Prescription | No | AB2 | 216633 | ZYDUS PHARMS |
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 | 216097 | AMNEAL PHARMS NY |
| ISOTRETINOIN | ISOTRETINOIN | 35MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |
| ISOTRETINOIN | ISOTRETINOIN | 35MG | CAPSULE;ORAL | Prescription | No | AB2 | 216633 | ZYDUS PHARMS |
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 | 216097 | AMNEAL PHARMS NY |
| ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB2 | 218194 | AUROBINDO PHARMA |
| ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB2 | 213571 | UPSHER SMITH LABS |
| ISOTRETINOIN | ISOTRETINOIN | 40MG | CAPSULE;ORAL | Prescription | No | AB2 | 216633 | ZYDUS PHARMS |