Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086577
Company: WATSON LABS
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 10/19/1982 | 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 |
|---|---|---|---|---|---|
| 02/19/1999 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/02/1999 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 12/04/1996 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 08/06/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/30/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/23/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/02/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |