Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201356
Company: INVAGEN PHARMS
Company: INVAGEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 20MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 25MG;EQ 20MG 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 |
|---|---|---|---|---|---|---|---|
| 04/20/2011 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/25/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/06/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/24/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/30/2015 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |