Application 019111
- Type
- NDA
- Sponsor
- UCB INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TUSSIONEX PENNKINETIC | CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX | SUSPENSION, EXTENDED RELEASE;ORAL | EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50474-150 | Tussionex Pennkinetic | hydrocodone and chlorpheniramine | UCB Inc. | NDA | Current |
| 53014-548 | Tussionex Pennkinetic | hydrocodone polistirex and chlorpheniramine polistirex | Unither Manufacturing LLC | NDA | Current |
| 62175-490 | Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic | hydrocodone polistirex and chlorpheniramine polistirex | Kremers Urban Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54848 | SUPPL | 2018-07-06 |
| 54789 | SUPPL | 2018-07-06 |
| 54752 | SUPPL | 2018-07-05 |
| 46887 | SUPPL | 2017-01-24 |
| 46870 | SUPPL | 2017-01-13 |
| 16197 | SUPPL | 2015-04-03 |
| 33698 | SUPPL | 2015-04-02 |
| 16196 | SUPPL | 2011-06-09 |
| 20206 | SUPPL | 2008-08-01 |
| 44029 | ORIG | 2008-03-13 |
| 16195 | SUPPL | 2008-03-13 |
| 11436 | SUPPL | 2008-03-13 |
| 1228 | SUPPL | 2003-11-25 |