Application 040660
- Type
- ANDA
- Sponsor
- VINTAGE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETH 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 |
|---|---|---|---|---|---|
| 0121-0925 | Promethazine VC with Codeine Oral Solution | Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0603-1588 | Promethazine VC with Codeine | Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate | Par Pharmaceutical | ANDA | Current |
| 55045-1266 | Promethazine VC With Codeine | Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23717 | ORIG | 2006-12-18 |