Application 007638
- Type
- NDA
- Sponsor
- BAYER HEALTHCARE LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CHLOR-TRIMETON | CHLORPHENIRAMINE MALEATE | TABLET, EXTENDED RELEASE;ORAL | 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | CHLOR-TRIMETON | CHLORPHENIRAMINE MALEATE | TABLET, EXTENDED RELEASE;ORAL | 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|
| 135 | SUPPL | 2015-12-29 |
| 40 | SUPPL | 2008-02-07 |
| 39 | SUPPL | 2006-01-30 |