Application 074725
- Type
- ANDA
- Sponsor
- PHARM ASSOC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | CONCENTRATE;ORAL | 5MG/ML | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0121-0653 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0653 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | Pharmaceutical Associates, Inc. | ANDA | Current |
| 70518-3553 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22353 | ORIG | 2011-05-06 |