Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075926
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/01/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75926ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2020 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/23/2006 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/21/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |