Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085383
Company: WOCKHARDT
Company: WOCKHARDT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTABARBITAL SODIUM | BUTABARBITAL SODIUM | 30MG/5ML | ELIXIR;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/26/1979 | 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 |
|---|---|---|---|---|---|
| 03/06/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/06/1989 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 10/10/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 08/20/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/29/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |