Application 089903
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | INJECTABLE;INJECTION | EQ 5MG BASE/ML | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0641-0491 | Prochlorperazine Edisylate | Prochlorperazine Edisylate | Baxter Healthcare Corporation | ANDA | Current |
| 0641-6135 | Prochlorperazine Edisylate | Prochlorperazine Edisylate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6135 | Prochlorperazine Edisylate | Prochlorperazine Edisylate | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 51662-1558 | PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 72572-580 | Prochlorperazine Edisylate | Prochlorperazine Edisylate | Civica, Inc. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 53905 | ORIG | 2018-05-01 |
| 39606 | SUPPL | 2013-01-09 |