Details for New Drug Application (NDA): 203393
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NDA 203393 describes MELPHALAN HYDROCHLORIDE, which is a drug marketed by Actavis Llc, Almaject, Arthur Grp, Avet Lifesciences, Bpi Labs, Dr Reddys, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hetero Labs, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Sagent Pharms Inc, and Uswm, and is included in eighteen NDAs. It is available from fifteen suppliers. Additional details are available on the MELPHALAN HYDROCHLORIDE profile page.
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.
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 203393
| Tradename: | MELPHALAN HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | melphalan hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203393
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 203393 | ANDA | Fresenius Kabi USA, LLC | 63323-760 | 63323-760-20 | 1 KIT in 1 CARTON (63323-760-20) * 10 mL in 1 VIAL, SINGLE-DOSE (63323-761-20) * 10 mL in 1 VIAL, SINGLE-USE (63323-732-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | Dec 22, 2017 | TE: | AP | RLD: | No | ||||
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