Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075783
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LISINOPRIL | LISINOPRIL | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 30MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 40MG | 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/2002/75783TA2.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/28/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/25/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/29/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/29/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/2002 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 10/29/2002 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |