Application 076755
- Type
- ANDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUMAZENIL | FLUMAZENIL | INJECTABLE;INJECTION | 1MG/10ML (0.1MG/ML) | No | No |
| 002 | FLUMAZENIL | FLUMAZENIL | INJECTABLE;INJECTION | 0.5MG/5ML (0.1MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0404-9859 | Flumazenil | flumazenil | Henry Schein, Inc | ANDA | Current |
| 0404-9859 | Flumazenil | flumazenil | Henry Schein, Inc | ANDA | Current |
| 0404-9860 | Flumazenil | flumazenil | Henry Schein, Inc | ANDA | Current |
| 0404-9860 | Flumazenil | flumazenil | Henry Schein, Inc | ANDA | Current |
| 36000-148 | Flumazenil | Flumazenil | Baxter Healthcare Corporation | ANDA | Current |
| 36000-148 | Flumazenil | Flumazenil | Baxter Healthcare Corporation | ANDA | Current |
| 36000-148 | Flumazenil | Flumazenil | Baxter Healthcare Corporation | ANDA | Current |
| 36000-148 | Flumazenil | Flumazenil | Baxter Healthcare Corporation | ANDA | Current |
| 36000-149 | Flumazenil | Flumazenil | Baxter Healthcare Corporation | ANDA | Current |
| 36000-149 | Flumazenil | Flumazenil | Baxter Healthcare Corporation | ANDA | Current |
| 36000-149 | Flumazenil | Flumazenil | Baxter Healthcare Corporation | ANDA | Current |
| 36000-149 | Flumazenil | Flumazenil | Baxter Healthcare Corporation | ANDA | Current |
| 52584-088 | Flumazenil | flumazenil | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-088 | Flumazenil | flumazenil | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-088 | Flumazenil | flumazenil | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-089 | Flumazenil | flumazenil | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-089 | Flumazenil | flumazenil | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-089 | Flumazenil | flumazenil | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-089 | Flumazenil | flumazenil | General Injectables and Vaccines, Inc. | ANDA | Current |
| 71872-7206 | Flumazenil | Flumazenil | Medical Purchasing Solutions, LLC | ANDA | Current |