Application 084307
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | INJECTABLE;INJECTION | 50MG/ML | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0404-9932 | Phenytoin Sodium | Phenytoin Sodium | Henry Schein, Inc. | ANDA | Current |
| 0404-9932 | Phenytoin Sodium | Phenytoin Sodium | Henry Schein, Inc. | ANDA | Current |
| 0404-9933 | Phenytoin Sodium | Phenytoin Sodium | Henry Schein, Inc. | ANDA | Current |
| 0404-9933 | Phenytoin Sodium | Phenytoin Sodium | Henry Schein, Inc. | ANDA | Current |
| 0641-0493 | Phenytoin Sodium | Phenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-0493 | Phenytoin Sodium | Phenytoin Sodium | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-0493 | Phenytoin Sodium | Phenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-2555 | Phenytoin Sodium | Phenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-2555 | Phenytoin Sodium | Phenytoin Sodium | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-2555 | Phenytoin Sodium | Phenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6138 | Phenytoin Sodium | Phenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6138 | Phenytoin Sodium | Phenytoin Sodium | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6138 | Phenytoin Sodium | Phenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6138 | Phenytoin Sodium | Phenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6139 | Phenytoin Sodium | Phenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6139 | Phenytoin Sodium | Phenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6139 | Phenytoin Sodium | Phenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6139 | Phenytoin Sodium | Phenytoin Sodium | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 51662-1250 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1250 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1250 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1250 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1251 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1251 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1251 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1251 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 52584-493 | Phenytoin Sodium | Phenytoin Sodium | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-493 | Phenytoin Sodium | Phenytoin Sodium | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-493 | Phenytoin Sodium | Phenytoin Sodium | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-493 | Phenytoin Sodium | Phenytoin Sodium | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-555 | Phenytoin Sodium | Phenytoin Sodium | General Injectables & Vaccines, Inc. | ANDA | Current |
| 52584-555 | Phenytoin Sodium | Phenytoin Sodium | General Injectables & Vaccines, Inc. | ANDA | Current |
| 52584-555 | Phenytoin Sodium | Phenytoin Sodium | General Injectables & Vaccines, Inc. | ANDA | Current |
| 52584-555 | Phenytoin Sodium | Phenytoin Sodium | General Injectables & Vaccines, Inc. | ANDA | Current |
| 55154-5117 | Phenytoin Sodium | Phenytoin Sodium | Cardinal Health | ANDA | Current |
| 55154-5117 | Phenytoin Sodium | Phenytoin Sodium | Cardinal Health | ANDA | Current |