Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085380
Company: MEDA PHARMS
Company: MEDA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTISOL 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 |
|---|---|---|---|---|---|---|---|
| 04/10/1978 | 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 |
|---|---|---|---|---|---|
| 05/03/2000 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/14/1999 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 03/13/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1992 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1992 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1992 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1990 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |