Details for New Drug Application (NDA): 078011
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NDA 078011 describes VINORELBINE TARTRATE, which is a drug marketed by Actavis Totowa, Dr Reddys, Ebewe Pharma, Fresenius Kabi Usa, Hikma, Hospira, Jiangsu Hansoh Pharm, Mylan Labs Ltd, Novast Labs, and Teva Pharms Usa, and is included in eleven NDAs. It is available from two suppliers. Additional details are available on the VINORELBINE TARTRATE profile page.
The generic ingredient in VINORELBINE TARTRATE is vinorelbine tartrate. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.
The generic ingredient in VINORELBINE TARTRATE is vinorelbine tartrate. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.
Summary for 078011
| Tradename: | VINORELBINE TARTRATE |
| Applicant: | Actavis Totowa |
| Ingredient: | vinorelbine tartrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078011
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VINORELBINE TARTRATE | vinorelbine tartrate | INJECTABLE;INJECTION | 078011 | ANDA | Actavis Pharma, Inc. | 45963-607 | 45963-607-55 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) / 1 mL in 1 VIAL, SINGLE-DOSE |
| VINORELBINE TARTRATE | vinorelbine tartrate | INJECTABLE;INJECTION | 078011 | ANDA | Actavis Pharma, Inc. | 45963-607 | 45963-607-56 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-56) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
| Approval Date: | Jul 22, 2009 | TE: | AP | RLD: | No | ||||
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