Application 200963
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML;5MG/5ML;6.25MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65162-694 | Promethazine HCl, Phenylephrine HCl, Codeine Phosphate | Promethazine, Phenylephrine, Codeine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-694 | Promethazine HCl, Phenylephrine HCl, Codeine Phosphate | Promethazine, Phenylephrine, Codeine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-694 | Promethazine HCl, Phenylephrine HCl, Codeine Phosphate | Promethazine, Phenylephrine, Codeine | Amneal Pharmaceuticals LLC | ANDA | Current |