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LIBRIUM | CHLORDIAZEPOXIDE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
LIBRIUM | CHLORDIAZEPOXIDE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
LIBRIUM | CHLORDIAZEPOXIDE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
02/24/1960 | 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 |
---|---|---|---|---|---|
12/16/2016 | SUPPL-49 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012249s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012249Orig1s049ltr.pdf | |
06/02/1983 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1982 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/26/1982 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/03/1980 | SUPPL-43 | Labeling |
Label is not available on this site. |
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10/25/1979 | SUPPL-42 | Labeling |
Label is not available on this site. |
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07/24/1978 | SUPPL-41 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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03/31/1978 | SUPPL-40 | Labeling |
Label is not available on this site. |
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02/18/1977 | SUPPL-39 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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02/18/1977 | SUPPL-38 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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12/14/1976 | SUPPL-36 | Labeling |
Label is not available on this site. |
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10/18/1976 | SUPPL-35 | Labeling |
Label is not available on this site. |
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04/29/1974 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/16/2016 | SUPPL-49 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012249s049lbl.pdf |