Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070799
Company: AM REGENT
Company: AM REGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 40MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 02/11/1987 | 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 |
|---|---|---|---|---|---|
| 06/21/2021 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/30/2001 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 11/07/1997 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/09/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 02/28/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/27/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 08/26/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 06/30/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |