Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084714
Company: ABC HOLDING
Company: ABC HOLDING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDRO-RESERP | HYDROCHLOROTHIAZIDE; RESERPINE | 50MG;0.125MG | 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 |
---|---|---|---|---|---|---|---|
11/20/1979 | 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 |
---|---|---|---|---|---|
03/19/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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12/31/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
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11/06/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
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02/11/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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11/02/1981 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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06/29/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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06/29/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |