Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080553
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THIAMINE HYDROCHLORIDE | THIAMINE 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 |
|---|---|---|---|---|---|---|---|
| 03/27/1974 | 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 |
|---|---|---|---|---|---|
| 05/23/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/05/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |