Details for New Drug Application (NDA): 076955
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NDA 076955 describes FLUMAZENIL, which is a drug marketed by Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Rising, Sagent Pharms, and Sandoz, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the FLUMAZENIL profile page.
The generic ingredient in FLUMAZENIL is flumazenil. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the flumazenil profile page.
The generic ingredient in FLUMAZENIL is flumazenil. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the flumazenil profile page.
Summary for 076955
| Tradename: | FLUMAZENIL |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | flumazenil |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076955
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUMAZENIL | flumazenil | INJECTABLE;INJECTION | 076955 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1579 | 51662-1579-1 | 5 mL in 1 VIAL, MULTI-DOSE (51662-1579-1) |
| FLUMAZENIL | flumazenil | INJECTABLE;INJECTION | 076955 | ANDA | Fresenius Kabi USA, LLC | 63323-424 | 63323-424-05 | 10 VIAL, MULTI-DOSE in 1 TRAY (63323-424-05) / 5 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/10ML (0.1MG/ML) | ||||
| Approval Date: | Oct 12, 2004 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/5ML (0.1MG/ML) | ||||
| Approval Date: | Oct 12, 2004 | TE: | AP | RLD: | No | ||||
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