Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077093
Company: MYLAN
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 03/28/2005 | 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 |
|---|---|---|---|---|---|
| 05/26/2022 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/26/2022 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/26/2022 | SUPPL-19 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 05/26/2022 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/16/2016 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/24/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/24/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/24/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/24/2015 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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| 01/10/2011 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |