Details for New Drug Application (NDA): 078527
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NDA 078527 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 078527
| Tradename: | FLUMAZENIL |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | flumazenil |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078527
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUMAZENIL | flumazenil | INJECTABLE;INJECTION | 078527 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9683 | 0143-9683-10 | 10 VIAL, MULTI-DOSE in 1 BOX (0143-9683-10) / 10 mL in 1 VIAL, MULTI-DOSE (0143-9683-01) |
| FLUMAZENIL | flumazenil | INJECTABLE;INJECTION | 078527 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9684 | 0143-9684-10 | 10 VIAL, MULTI-DOSE in 1 BOX (0143-9684-10) / 5 mL in 1 VIAL, MULTI-DOSE (0143-9684-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/5ML (0.1MG/ML) | ||||
| Approval Date: | Mar 23, 2009 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/10ML (0.1MG/ML) | ||||
| Approval Date: | Mar 23, 2009 | TE: | AP | RLD: | No | ||||
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