Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078457
Company: INVAGEN PHARMS
Company: INVAGEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | EQ 40MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 08/24/2007 | 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 |
|---|---|---|---|---|---|
| 11/06/2019 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/25/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/25/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/17/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/28/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |