Details for New Drug Application (NDA): 020892
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NDA 020892 describes VALSTAR PRESERVATIVE FREE, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. Additional details are available on the VALSTAR PRESERVATIVE FREE profile page.
The generic ingredient in VALSTAR PRESERVATIVE FREE is valrubicin. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the valrubicin profile page.
The generic ingredient in VALSTAR PRESERVATIVE FREE is valrubicin. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the valrubicin profile page.
Summary for 020892
| Tradename: | VALSTAR PRESERVATIVE FREE |
| Applicant: | Endo Operations |
| Ingredient: | valrubicin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020892
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALSTAR PRESERVATIVE FREE | valrubicin | SOLUTION;INTRAVESICAL | 020892 | NDA | Endo USA, Inc. | 67979-001 | 67979-001-01 | 4 VIAL in 1 CARTON (67979-001-01) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVESICAL | Strength | 40MG/ML | ||||
| Approval Date: | Sep 25, 1998 | TE: | AO | RLD: | Yes | ||||
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