Application 022439
- Type
- NDA
- Sponsor
- PERSION
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZUTRIPRO | CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE | SOLUTION;ORAL | 4MG/5ML;5MG/5ML;60MG/5ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60258-876 | Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl | hydrocodone bitartrate, chlorpheniramine maleate, pseudoephedrine hydrochloride | Cypress Pharmaceutical, Inc. | NDA | Current |
| 63717-876 | ZUTRIPRO | hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride | Hawthorn Pharmaceuticals, Inc. | NDA | Current |