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Details for New Drug Application (NDA): 020388
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The generic ingredient in NAVELBINE is vinorelbine tartrate. There are fifteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.
Summary for 020388
Tradename: | NAVELBINE |
Applicant: | Pierre Fabre |
Ingredient: | vinorelbine tartrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020388
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAVELBINE | vinorelbine tartrate | INJECTABLE;INJECTION | 020388 | NDA | Pierre Fabre Pharmaceuticals, Inc. | 64370-532 | 64370-532-01 | 1 VIAL, SINGLE-USE in 1 CARTON (64370-532-01) > 1 mL in 1 VIAL, SINGLE-USE |
NAVELBINE | vinorelbine tartrate | INJECTABLE;INJECTION | 020388 | NDA | Pierre Fabre Pharmaceuticals, Inc. | 64370-532 | 64370-532-02 | 1 VIAL, SINGLE-USE in 1 CARTON (64370-532-02) > 5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
Approval Date: | Dec 23, 1994 | TE: | RLD: | Yes |
Expired US Patents for NDA 020388
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pierre Fabre | NAVELBINE | vinorelbine tartrate | INJECTABLE;INJECTION | 020388-001 | Dec 23, 1994 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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