Details for New Drug Application (NDA): 209197
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The generic ingredient in MELPHALAN HYDROCHLORIDE 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 209197
Tradename: | MELPHALAN HYDROCHLORIDE |
Applicant: | Bpi Labs |
Ingredient: | melphalan hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 209197
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 209197 | ANDA | BPI Labs LLC | 54288-109 | 54288-109-02 | 1 KIT in 1 CARTON (54288-109-02) * 10 mL in 1 VIAL, SINGLE-DOSE (54288-106-01) * 10 mL in 1 VIAL, SINGLE-USE (54288-107-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/VIAL | ||||
Approval Date: | May 8, 2020 | TE: | AP | RLD: | No |
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