Details for New Drug Application (NDA): 206523
NDA 206523 describes MELPHALAN HYDROCHLORIDE, which is a drug marketed by Actavis Llc, Almaject, Avet Lifesciences, Bpi Labs, Dr Reddys, Fresenius Kabi Usa, Gland, Hetero Labs, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Ph Health, Quagen, Sagent Pharms Inc, and Uswm, and is included in eighteen NDAs. It is available from thirteen suppliers. Additional details are available on the MELPHALAN HYDROCHLORIDE profile page.
The generic ingredient in MELPHALAN HYDROCHLORIDE is melphalan hydrochloride. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
The generic ingredient in MELPHALAN HYDROCHLORIDE is melphalan hydrochloride. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
Summary for 206523
| Tradename: | MELPHALAN HYDROCHLORIDE |
| Applicant: | Avet Lifesciences |
| Ingredient: | melphalan hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206523
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 206523 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-355 | 23155-355-41 | 1 KIT in 1 CARTON (23155-355-41) * 10 mL in 1 VIAL (23155-353-31) * 10 mL in 1 VIAL (23155-354-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | Oct 29, 2024 | TE: | AP | RLD: | No | ||||
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