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
AKPENTOLATE از شرکت AKORN
Abbreviated New Drug Application (ANDA): 040164
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AKPENTOLATE | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription |
AT |
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 |
|---|---|---|---|---|---|---|---|
| 01/13/1997 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/19/2017 | SUPPL-8 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/25/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/13/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2001 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/09/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/2001 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/07/1999 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
AKPENTOLATE
SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AKPENTOLATE | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040164 | AKORN |
| CYCLOGYL | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 084110 | ALCON LABS INC |
| PENTOLAIR | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040075 | BAUSCH AND LOMB |
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