Application 012249
- Type
- NDA
- Sponsor
- VALEANT PHARM INTL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LIBRIUM | CHLORDIAZEPOXIDE HYDROCHLORIDE | CAPSULE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | LIBRIUM | CHLORDIAZEPOXIDE HYDROCHLORIDE | CAPSULE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | LIBRIUM | CHLORDIAZEPOXIDE HYDROCHLORIDE | CAPSULE;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 46583 | SUPPL | 2016-12-29 |
| 46452 | SUPPL | 2016-12-21 |
| 46311 | SUPPL | 2016-12-20 |