Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 015103
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEMI-REGROTON | CHLORTHALIDONE; RESERPINE | 25MG;0.125MG | TABLET;ORAL | Discontinued | None | No | No |
| REGROTON | CHLORTHALIDONE; RESERPINE | 50MG;0.25MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/08/1964 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/26/1988 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 09/15/1987 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 09/04/1986 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 01/08/1985 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/18/1983 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 06/03/1983 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/21/1977 | SUPPL-32 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/07/1977 | SUPPL-31 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 03/01/1977 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 11/12/1976 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/03/1976 | SUPPL-27 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/08/1976 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/08/1975 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/17/1975 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/17/1975 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/17/1975 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |