Application 204627
- Type
- ANDA
- Sponsor
- PADDOCK LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE | SOLUTION;ORAL | 4MG/5ML;5MG/5ML;60MG/5ML | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0574-1103 | Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride | Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride | Paddock Laboratories, LLC | ANDA | Current |
| 0574-1103 | Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride | Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride | Paddock Laboratories, LLC | ANDA | Current |