Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020269
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% | DOBUTAMINE HYDROCHLORIDE | EQ 50MG BASE/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% | DOBUTAMINE HYDROCHLORIDE | EQ 100MG BASE/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% | DOBUTAMINE HYDROCHLORIDE | EQ 200MG BASE/100ML | 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 |
|---|---|---|---|---|---|---|---|
| 09/27/1993 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/17/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 08/03/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1996 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/24/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/19/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |