Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018398
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| 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 |
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 80MG/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 |
|---|---|---|---|---|---|---|---|
| 07/06/1981 | 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 |
|---|---|---|---|---|---|
| 08/04/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 10/17/1997 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/30/1996 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 07/29/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 04/28/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/28/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/17/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |