Drugs@FDA: FDA-Approved Drugs
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDRA-ZIDE | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 50MG;50MG | CAPSULE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/21/1985 | 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-22 | Labeling-Package Insert |
Label is not available on this site. |
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11/26/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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11/26/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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02/03/1995 | SUPPL-16 | Labeling |
Label is not available on this site. |
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06/14/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
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04/04/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
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05/08/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
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01/26/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
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11/29/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/10/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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01/10/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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04/05/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |