Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086961
Company: STRIDES PHARMA INTL
Company: STRIDES PHARMA INTL
| 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 |
|---|---|---|---|---|---|---|---|
| 02/27/1980 | 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 |
|---|---|---|---|---|---|
| 12/11/2001 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/04/1988 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 07/14/1988 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 05/08/1985 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/1983 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/1983 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/16/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |