Details for New Drug Application (NDA): 019763
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NDA 019763 describes IFEX/MESNEX KIT, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from three suppliers. Additional details are available on the IFEX/MESNEX KIT profile page.
The generic ingredient in IFEX/MESNEX KIT is ifosfamide; mesna. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ifosfamide; mesna profile page.
The generic ingredient in IFEX/MESNEX KIT is ifosfamide; mesna. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ifosfamide; mesna profile page.
Summary for 019763
| Tradename: | IFEX/MESNEX KIT |
| Applicant: | Baxter Hlthcare |
| Ingredient: | ifosfamide; mesna |
| Patents: | 0 |
Pharmacology for NDA: 019763
| Mechanism of Action | Alkylating Activity |
Suppliers and Packaging for NDA: 019763
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IFEX | ifosfamide | INJECTABLE;INJECTION | 019763 | NDA | Baxter Healthcare Corporation | 0338-3991 | 0338-3991-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-3991-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
| IFEX | ifosfamide | INJECTABLE;INJECTION | 019763 | NDA | Baxter Healthcare Corporation | 0338-3993 | 0338-3993-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-3993-01) / 60 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 30, 1988 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 30, 1988 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL;100MG/ML | ||||
| Approval Date: | Oct 10, 1992 | TE: | RLD: | No | |||||
Expired US Patents for NDA 019763
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | IFEX/MESNEX KIT | ifosfamide; mesna | INJECTABLE;INJECTION | 019763-004 | Oct 10, 1992 | ⤷ Subscribe | ⤷ Subscribe |
| Baxter Hlthcare | IFEX/MESNEX KIT | ifosfamide; mesna | INJECTABLE;INJECTION | 019763-003 | Oct 10, 1992 | ⤷ Subscribe | ⤷ Subscribe |
| Baxter Hlthcare | IFEX/MESNEX KIT | ifosfamide; mesna | INJECTABLE;INJECTION | 019763-004 | Oct 10, 1992 | ⤷ Subscribe | ⤷ Subscribe |
| Baxter Hlthcare | IFEX | ifosfamide | INJECTABLE;INJECTION | 019763-001 | Dec 30, 1988 | ⤷ Subscribe | ⤷ Subscribe |
| Baxter Hlthcare | IFEX/MESNEX KIT | ifosfamide; mesna | INJECTABLE;INJECTION | 019763-003 | Oct 10, 1992 | ⤷ Subscribe | ⤷ Subscribe |
| Baxter Hlthcare | IFEX/MESNEX KIT | ifosfamide; mesna | INJECTABLE;INJECTION | 019763-003 | Oct 10, 1992 | ⤷ Subscribe | ⤷ Subscribe |
| Baxter Hlthcare | IFEX | ifosfamide | INJECTABLE;INJECTION | 019763-002 | Dec 30, 1988 | ⤷ Subscribe | ⤷ Subscribe |
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