Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083560
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 08/05/1976 | 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 |
|---|---|---|---|---|---|
| 01/28/2000 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/27/1987 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/27/1987 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/06/1985 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/1985 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/1985 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/1985 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/15/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/15/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/15/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/15/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |