Home NDC 69605-001-01 EVOMELA
Product NDC 69605-001
Requested package NDC 69605-001-01
11-digit product format 696050001
Labeler code 69605
Product ID 69605-001_d44fac6f-e1e1-399d-e053-2a95a90a81f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Melphalan
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler CENEXI - BLA
Application NDA207155
Marketing category NDA
Marketing start 2016-03-31
Marketing end 0000-00-00
Substance MELPHALAN HYDROCHLORIDE
Active strength 50 mg/10mL
Pharmacologic classes Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N207155-001 EVOMELA MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207155-001 8410077 2029-03-13 Drug product 2016-04-05 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 N207155-001 10040872 2034-01-30 Drug product 2018-09-06
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 1 of 2 · 43 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 2026-09-14 22:38:34 2026-08 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 7 · 280 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207155-001 10040872 2034-01-30 Drug product 2018-09-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207155-001 10040872 2034-01-30 Drug product 2018-09-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 10040872 2034-01-30 Drug product 2018-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 10040872 2034-01-30 Drug product 2018-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 10040872 2034-01-30 Drug product 2018-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 fd3edfee7708…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69605-001-01 69605000101 1 VIAL in 1 CARTON (69605-001-01) > 20 mL in 1 VIAL 1 vial 2016-03-31 0000-00-00 No No Current