Drugs@FDA: FDA-Approved Drugs
Company: VALEANT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHRENILIN | ACETAMINOPHEN; BUTALBITAL | 325MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 12/13/2014 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/10/2011 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/03/2003 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 12/06/2001 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/25/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/25/2001 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/26/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/28/1997 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 04/28/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1994 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 12/07/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 05/15/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 05/08/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/04/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/01/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 03/27/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/05/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/05/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |