Drugs@FDA: FDA-Approved Drugs
Company: VALEANT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHRENILIN FORTE | ACETAMINOPHEN; BUTALBITAL | 650MG;50MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 06/19/1985 | 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 |
|---|---|---|---|---|---|
| 05/08/2002 | SUPPL-29 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/19/2002 | SUPPL-28 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/06/2001 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/16/2001 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/2000 | SUPPL-25 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/09/2000 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/27/2000 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/27/2000 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/2000 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1997 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/28/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1994 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 12/07/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/08/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/01/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/28/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/02/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/12/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |