Application 074531
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUPHENAZINE DECANOATE | FLUPHENAZINE DECANOATE | INJECTABLE;INJECTION | 25MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9529 | Fluphenazine Decanoate | Fluphenazine Decanoate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9529 | Fluphenazine Decanoate | Fluphenazine Decanoate | West-Ward Pharmaceuticals Corp | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53901 | ORIG | 2018-05-01 |
| 42853 | SUPPL | 2013-04-11 |