Application 078527
- Type
- ANDA
- Sponsor
- HIKMA FARMACEUTICA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUMAZENIL | FLUMAZENIL | INJECTABLE;INJECTION | 0.5MG/5ML (0.1MG/ML) | No | No |
| 002 | FLUMAZENIL | FLUMAZENIL | INJECTABLE;INJECTION | 1MG/10ML (0.1MG/ML) | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9683 | Flumazenil | Flumazenil | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9683 | Flumazenil | Flumazenil | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9684 | Flumazenil | Flumazenil | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9684 | Flumazenil | Flumazenil | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9783 | Flumazenil | flumazenil | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9784 | Flumazenil | flumazenil | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 50090-1337 | Flumazenil | flumazenil | A-S Medication Solutions | ANDA | Current |
| 50090-1337 | Flumazenil | flumazenil | A-S Medication Solutions | ANDA | Current |
| 51662-1253 | FLUMAZENIL | FLUMAZENIL | HF Acquisition Co. LLC, DBA Health First | ANDA | Current |
| 51662-1253 | FLUMAZENIL | FLUMAZENIL | HF Acquisition Co. LLC, DBA Health First | ANDA | Current |
| 51662-1253 | FLUMAZENIL | FLUMAZENIL | HF Acquisition Co. LLC, DBA Health First | ANDA | Current |
| 51662-1253 | FLUMAZENIL | FLUMAZENIL | HF Acquisition Co. LLC, DBA Health First | ANDA | Current |
| 51662-1254 | FLUMAZENIL | FLUMAZENIL | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1254 | FLUMAZENIL | FLUMAZENIL | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1254 | FLUMAZENIL | FLUMAZENIL | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1254 | FLUMAZENIL | FLUMAZENIL | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 52584-783 | Flumazenil | Flumazenil | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-783 | Flumazenil | Flumazenil | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-784 | Flumazenil | Flumazenil | General Injectables and Vaccines, Inc | ANDA | Current |
| 52584-784 | Flumazenil | Flumazenil | General Injectables and Vaccines, Inc | ANDA | Current |
| 55154-7474 | Flumazenil | flumazenil | Cardinal Health | ANDA | Current |
| 70385-2002 | Flumazenil | flumazenil | Sina Health Inc | ANDA | Current |
| 70385-2021 | Flumazenil | flumazenil | Sina Health Inc | ANDA | Current |
| 71872-7008 | Flumazenil | flumazenil | Medical Purchasing Solutions, LLC | ANDA | Current |
| 71872-7008 | Flumazenil | flumazenil | Medical Purchasing Solutions, LLC | ANDA | Current |
| 71872-7008 | Flumazenil | flumazenil | Medical Purchasing Solutions, LLC | ANDA | Current |
| 71872-7038 | Flumazenil | flumazenil | Medical Purchasing Solutions, LLC | ANDA | Current |
| 71872-7038 | Flumazenil | flumazenil | Medical Purchasing Solutions, LLC | ANDA | Current |