Application 040688
- Type
- ANDA
- Sponsor
- WRASER PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE | ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE | CAPSULE;ORAL | 356.4MG;30MG;16MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66992-340 | Trezix | acetaminophen, caffeine, dihydrocodeine bitartrate | WraSer LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53883 | ORIG | 2018-05-01 |