Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088804
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIMETHOBENZAMIDE HYDROCHLORIDE | TRIMETHOBENZAMIDE HYDROCHLORIDE | 100MG/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 |
|---|---|---|---|---|---|---|---|
| 04/03/1987 | 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 |
|---|---|---|---|---|---|
| 02/14/2001 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/05/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/16/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/22/1995 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 03/26/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/03/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/17/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |