Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076116
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET;ORAL | Discontinued | None | No | No |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | 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 |
---|---|---|---|---|---|---|---|
09/19/2001 | 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 |
---|---|---|---|---|---|
12/11/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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12/11/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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12/11/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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12/11/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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01/12/2011 | SUPPL-7 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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05/29/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
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09/05/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
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01/08/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |