Application 088704
- Type
- ANDA
- Sponsor
- STI PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIACIN-C | CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML;30MG/5ML;1.25MG/5ML | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 54879-005 | Triacin-C | TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP | STI Pharma LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53926 | ORIG | 2018-05-01 |