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Details for New Drug Application (NDA): 021037
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NDA 021037 describes MAGNEVIST, which is a drug marketed by Bayer Hlthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the MAGNEVIST profile page.
The generic ingredient in MAGNEVIST is gadopentetate dimeglumine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadopentetate dimeglumine profile page.
The generic ingredient in MAGNEVIST is gadopentetate dimeglumine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadopentetate dimeglumine profile page.
Summary for 021037
| Tradename: | MAGNEVIST |
| Applicant: | Bayer Hlthcare |
| Ingredient: | gadopentetate dimeglumine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021037
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 021037 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-188 | 50419-188-11 | 10 VIAL, PHARMACY BULK PACKAGE in 1 BOX (50419-188-11) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 021037 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-188 | 50419-188-58 | 10 VIAL, PHARMACY BULK PACKAGE in 1 BOX (50419-188-58) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 469.01MG/ML | ||||
| Approval Date: | Mar 10, 2000 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021037
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 021037-001 | Mar 10, 2000 | Start Trial | Start Trial |
| Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 021037-001 | Mar 10, 2000 | Start Trial | Start Trial |
| Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 021037-001 | Mar 10, 2000 | Start Trial | Start Trial |
| Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 021037-001 | Mar 10, 2000 | Start Trial | Start Trial |
| Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 021037-001 | Mar 10, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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