Application 089647
- Type
- ANDA
- Sponsor
- PHARM ASSOC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML;6.25MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0121-0547 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | Pharmaceutical Associates, Inc. | ANDA | Current |