Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085555
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AK-PENTOLATE | CYCLOPENTOLATE HYDROCHLORIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 04/10/1979 | 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 |
|---|---|---|---|---|---|
| 03/18/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/13/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/25/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |