Details for New Drug Application (NDA): 209197
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NDA 209197 describes MELPHALAN HYDROCHLORIDE, which is a drug marketed by Actavis Llc, Almaject, Arthur Grp, 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 seventeen NDAs. It is available from fourteen 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. 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 are twelve drug master file entries for this compound. Sixteen 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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