Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084897
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAM-AP-ES | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE | 25MG;15MG;0.1MG | 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/06/2000 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/06/1992 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 02/11/1992 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 03/15/1991 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 05/09/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 06/02/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/30/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |