Application 091675
- Type
- ANDA
- Sponsor
- TRIS PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 6.25MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27808-051 | promethazine hydrochloride | promethazine hydrochloride | Tris Pharma Inc | ANDA | Current |
| 27808-051 | Promethazine Hydrochloride | Promethazine Hydrochloride | Tris Pharma Inc | ANDA | Current |
| 27808-051 | promethazine hydrochloride | promethazine hydrochloride | Tris Pharma Inc | ANDA | Current |