Is there a generic for Melphalan?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Melphalan, referencing the brand ALKERAN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Melphalan?

ALKERAN (NDA 014691, APOTEX) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Melphalan are approved?

Melphalan is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Melphalan

Melphalan is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ALKERAN · NDA 014691

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
ALKERANRLD	APOTEX	NDA 014691	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
MELPHALAN	ALVOGEN	ANDA 207809	—	Mar 22, 2017

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Melphalan — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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