Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074292
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOBUTAMINE HYDROCHLORIDE | DOBUTAMINE HYDROCHLORIDE | EQ 12.5MG BASE/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 |
---|---|---|---|---|---|---|---|
02/16/1995 | 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 |
---|---|---|---|---|---|
02/14/2001 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/23/1997 | SUPPL-7 | Labeling |
Label is not available on this site. |
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12/24/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
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01/28/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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01/28/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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06/07/1996 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/07/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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06/07/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |