Drugs@FDA: FDA-Approved Drugs
Company: VALEANT PHARM INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DALMANE | FLURAZEPAM HYDROCHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | No | No |
| DALMANE | FLURAZEPAM HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/07/1970 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/27/2009 | SUPPL-77 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016721s077ltr.pdf | |
| 10/30/2007 | SUPPL-76 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016721s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016721s076,s058ltr.pdf | |
| 08/12/2002 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/2001 | SUPPL-74 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16721s74ltr.pdf |
| 05/25/1993 | SUPPL-72 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/31/1992 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1990 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1990 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1989 | SUPPL-67 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/09/1987 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 12/11/1984 | SUPPL-64 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/15/1982 | SUPPL-63 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/28/1982 | SUPPL-62 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/22/1981 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/22/1981 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1981 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1981 | SUPPL-57 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/17/1981 | SUPPL-56 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/26/1981 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1981 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 08/20/1980 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1980 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1980 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/17/1980 | SUPPL-49 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/17/1980 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/04/1980 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1979 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1979 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1979 | SUPPL-44 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/26/1979 | SUPPL-43 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/28/1978 | SUPPL-42 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/12/1978 | SUPPL-41 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/20/1978 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 07/10/1978 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 05/02/1978 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1977 | SUPPL-37 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/29/1977 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/1977 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 12/10/1976 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 07/10/1978 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/01/1975 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1975 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1974 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/22/1974 | SUPPL-23 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/27/2009 | SUPPL-77 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf | |
| 10/30/2007 | SUPPL-76 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016721s076lbl.pdf |