Home Applications 014691 Application 014691
Type NDA
Sponsor APOTEX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 ALKERAN MELPHALAN TABLET;ORAL 2MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N014691-002 ALKERAN MELPHALAN 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N014691-002 ALKERAN 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N014691-002 ALKERAN 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N014691-002 ALKERAN 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N014691-002 ALKERAN 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52609-0001 ALKERAN melphalan ApoPharma USA, Inc. NDA Current 52609-0001 ALKERAN melphalan ApoPharma USA, Inc. NDA Current 52609-0001 ALKERAN melphalan ApoPharma USA, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 33124 SUPPL 2011-06-14 12071 SUPPL 2011-06-14 383 SUPPL 2011-05-04 10848 SUPPL 2011-05-02 382 SUPPL 2005-06-14 40695 SUPPL 2003-07-05 12070 SUPPL 2003-06-08 10847 SUPPL 2003-05-28 381 SUPPL 2002-01-07 380 SUPPL 2001-05-24