Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040165
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AKPENTOLATE | CYCLOPENTOLATE HYDROCHLORIDE | 2% | 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-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
07/25/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
10/09/2001 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/09/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
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; 2%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AKPENTOLATE | CYCLOPENTOLATE HYDROCHLORIDE | 2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040165 | RISING |
CYCLOGYL | CYCLOPENTOLATE HYDROCHLORIDE | 2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 084108 | ALCON LABS INC |