Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087939
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 |
---|---|---|---|---|---|---|---|
12/28/1982 | 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 |
---|---|---|---|---|---|
08/16/1995 | SUPPL-9 | Manufacturing (CMC) |
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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05/08/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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12/27/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
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12/01/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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12/01/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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04/29/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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08/28/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |