Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085098
Company: IMPAX LABS
Company: IMPAX LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 100MG | 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 |
---|---|---|---|---|---|---|---|
07/15/1977 | 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 |
---|---|---|---|---|---|
03/16/2001 | SUPPL-25 | Labeling |
Label is not available on this site. |
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03/16/2001 | SUPPL-24 | Labeling |
Label is not available on this site. |
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01/16/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |
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04/06/1990 | SUPPL-22 | Labeling |
Label is not available on this site. |
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01/23/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
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11/09/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
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09/18/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |