اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ACITRETIN از شرکت IMPAX LABS INC
Abbreviated New Drug Application (ANDA): 202552
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACITRETIN | ACITRETIN | 10MG | CAPSULE;ORAL | Prescription |
AB |
No | No |
| ACITRETIN | ACITRETIN | 17.5MG | CAPSULE;ORAL | Prescription |
AB |
No | No |
| ACITRETIN | ACITRETIN | 22.5MG | CAPSULE;ORAL | Prescription |
AB |
No | No |
| ACITRETIN | ACITRETIN | 25MG | CAPSULE;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 12/23/2015 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202552Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/07/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2018 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2017 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
ACITRETIN
CAPSULE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACITRETIN | ACITRETIN | 10MG | CAPSULE;ORAL | Prescription | No | AB | 091455 | BARR LABS INC |
| ACITRETIN | ACITRETIN | 10MG | CAPSULE;ORAL | Prescription | No | AB | 202552 | IMPAX LABS INC |
| ACITRETIN | ACITRETIN | 10MG | CAPSULE;ORAL | Prescription | No | AB | 202148 | MYLAN |
| ACITRETIN | ACITRETIN | 10MG | CAPSULE;ORAL | Prescription | No | AB | 204633 | SIGMAPHARM LABS LLC |
CAPSULE;ORAL; 17.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACITRETIN | ACITRETIN | 17.5MG | CAPSULE;ORAL | Prescription | No | AB | 202552 | IMPAX LABS INC |
| ACITRETIN | ACITRETIN | 17.5MG | CAPSULE;ORAL | Prescription | No | AB | 204633 | SIGMAPHARM LABS LLC |
| ACITRETIN | ACITRETIN | 17.5MG | CAPSULE;ORAL | Prescription | No | AB | 202897 | TEVA PHARMS USA |
CAPSULE;ORAL; 22.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACITRETIN | ACITRETIN | 22.5MG | CAPSULE;ORAL | Prescription | No | AB | 202552 | IMPAX LABS INC |
| ACITRETIN | ACITRETIN | 22.5MG | CAPSULE;ORAL | Prescription | No | AB | 204633 | SIGMAPHARM LABS LLC |
| ACITRETIN | ACITRETIN | 22.5MG | CAPSULE;ORAL | Prescription | No | AB | 202897 | TEVA PHARMS USA |
CAPSULE;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACITRETIN | ACITRETIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 091455 | BARR LABS INC |
| ACITRETIN | ACITRETIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 202552 | IMPAX LABS INC |
| ACITRETIN | ACITRETIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 202148 | MYLAN |
| ACITRETIN | ACITRETIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 204633 | SIGMAPHARM LABS LLC |
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