Application 088763
- Type
- ANDA
- Sponsor
- ACTAVIS MID ATLANTIC
Application Products#
Product, Drug, Ingredient table| 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 | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42254-140 | Prometh with Codeine | Promethazine Hydrochloride and Codeine Phosphate | Rebel Distributors Corp | ANDA | Current |