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Details for New Drug Application (NDA): 075493
NDA 075493 describes VINCRISTINE SULFATE PFS, which is a drug marketed by Hospira and Teva Pharms Usa and is included in two NDAs. It is available from two suppliers. Additional details are available on the VINCRISTINE SULFATE PFS profile page.
The generic ingredient in VINCRISTINE SULFATE PFS is vincristine sulfate. There are thirteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the vincristine sulfate profile page.
The generic ingredient in VINCRISTINE SULFATE PFS is vincristine sulfate. There are thirteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the vincristine sulfate profile page.
Summary for 075493
| Tradename: | VINCRISTINE SULFATE PFS |
| Applicant: | Teva Pharms Usa |
| Ingredient: | vincristine sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075493
| Ingredient-type | Vinca Alkaloids |
Medical Subject Heading (MeSH) Categories for 075493
Suppliers and Packaging for NDA: 075493
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VINCRISTINE SULFATE PFS | vincristine sulfate | INJECTABLE;INJECTION | 075493 | ANDA | Teva Parenteral Medicines, Inc. | 0703-4402 | 0703-4402-11 | 1 VIAL, SINGLE-USE in 1 CARTON (0703-4402-11) > 1 mL in 1 VIAL, SINGLE-USE |
| VINCRISTINE SULFATE PFS | vincristine sulfate | INJECTABLE;INJECTION | 075493 | ANDA | Teva Parenteral Medicines, Inc. | 0703-4412 | 0703-4412-11 | 1 VIAL, SINGLE-USE in 1 CARTON (0703-4412-11) > 2 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Sep 1, 1999 | TE: | AP | RLD: | No | ||||
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