Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085088
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 | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/16/1994 | 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 |
|---|---|---|---|---|---|
| 11/03/1983 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1983 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1983 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |