Drugs@FDA: FDA-Approved Drugs
Company: VALEANT PHARM INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIBRIUM | CHLORDIAZEPOXIDE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/21/1977 | 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 |
|---|---|---|---|---|---|
| 01/17/2023 | SUPPL-58 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2021 | SUPPL-56 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-55 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-49 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-45 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-44 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/20/1997 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1997 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1994 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 03/27/1991 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1989 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 04/07/1989 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1988 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 11/02/1987 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1984 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1983 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1982 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1982 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1982 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
LIBRIUM
CAPSULE;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE HYDROCHLORIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 084768 | BARR |
| CHLORDIAZEPOXIDE HYDROCHLORIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 084678 | CHARTWELL RX |
| LIBRIUM | CHLORDIAZEPOXIDE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | Yes | AB | 085461 | VALEANT PHARM INTL |