Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212333
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
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 | 30MG | 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 |
---|---|---|---|---|---|---|---|
09/21/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212333Orig1s000TAltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/24/2023 | SUPPL-8 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
10/06/2022 | SUPPL-6 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
08/24/2022 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
10/08/2021 | 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 | 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 |