Details for New Drug Application (NDA): 217110
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NDA 217110 describes IVRA, which is a drug marketed by Apotex and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the IVRA profile page.
The generic ingredient in IVRA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
The generic ingredient in IVRA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
Summary for 217110
| Tradename: | IVRA |
| Applicant: | Apotex |
| Ingredient: | melphalan hydrochloride |
| Patents: | 1 |
Pharmacology for NDA: 217110
| Mechanism of Action | Alkylating Activity |
Suppliers and Packaging for NDA: 217110
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IVRA | melphalan hydrochloride | SOLUTION;INTRAVENOUS | 217110 | NDA | Apotex Corp | 60505-6414 | 60505-6414-1 | 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6414-1) / 3 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 90MG BASE/ML (EQ 90MG BASE/ML) | ||||
| Approval Date: | Aug 18, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jun 29, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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