Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076265
Company: HIKMA INTL PHARMS
Company: HIKMA INTL PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 07/08/2002 | 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/03/2020 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/03/2020 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/26/2015 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/26/2015 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/26/2015 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/26/2015 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/11/2013 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/11/2013 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/11/2013 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/03/2010 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/03/2010 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 04/09/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 08/08/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |