Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088846
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/26/1985 | 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 |
|---|---|---|---|---|---|
| 10/06/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 09/09/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 02/14/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/10/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/13/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |