Home Applications 215014 Application 215014
Type NDA
Sponsor APELLIS PHARMACEUTICALS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EMPAVELI PEGCETACOPLAN INJECTABLE;INJECTION 1080MG/20ML(54MG/ML) No No
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 N215014-001 EMPAVELI PEGCETACOPLAN 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14
Orange Book patents# Current patent rows page 1 of 1 · 27 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215014-001 9169307 2027-11-18 U-3123 Drug substance 2021-06-09 N215014-001 9169307 2027-11-18 U-4244 Drug substance 2021-06-09 N215014-001 7888323 2027-12-04 Drug substance 2021-06-09 N215014-001 7989589 2027-12-04 Drug substance 2021-06-09 N215014-001 11661441 2033-01-13 U-3124 Drug substance 2023-06-23 N215014-001 11661441 2033-01-13 U-4242 Drug substance 2023-06-23 N215014-001 10125171 2033-08-02 Drug substance 2021-06-09 N215014-001 10035822 2033-11-15 Drug substance 2021-06-09 N215014-001 10875893 2033-11-15 U-3124 Drug substance 2021-06-09 N215014-001 10875893 2033-11-15 U-4242 Drug substance 2021-06-09 N215014-001 11292815 2033-11-15 U-3124 Drug substance, Drug product 2022-04-29 N215014-001 11292815 2033-11-15 U-3354 Drug substance, Drug product 2022-04-29 N215014-001 11292815 2033-11-15 U-4242 Drug substance, Drug product 2022-04-29 N215014-001 11292815 2033-11-15 U-4243 Drug substance, Drug product 2022-04-29 N215014-001 11040107 2038-04-09 U-3172 Drug product 2021-07-16 N215014-001 11040107 2038-04-09 U-3173 Drug product 2021-07-16 N215014-001 11040107 2038-04-09 U-3174 Drug product 2021-07-16 N215014-001 11040107 2038-04-09 U-4241 Drug product 2021-07-16 N215014-001 11844841 2038-12-09 U-3172 Drug product 2024-01-16 N215014-001 11844841 2038-12-09 U-3173 Drug product 2024-01-16 N215014-001 11844841 2038-12-09 U-3174 Drug product 2024-01-16 N215014-001 11844841 2038-12-09 U-4241 Drug product 2024-01-16 N215014-001 12290566 2038-12-14 U-4174 Drug product 2025-05-07 N215014-001 12290566 2038-12-14 U-4175 Drug product 2025-05-07 N215014-001 12290566 2038-12-14 U-4238 Drug product 2025-05-07 N215014-001 12290566 2038-12-14 U-4239 Drug product 2025-05-07 N215014-001 12290566 2038-12-14 U-4240 Drug product 2025-05-07
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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.
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 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215014-001 EMPAVELI 1080MG/20ML (54MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-05-14 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 13 · 519 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 N215014-001 9169307 2027-11-18 U-4244 Drug substance 2021-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 9169307 2027-11-18 U-3123 Drug substance 2021-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 7888323 2027-12-04 Drug substance 2021-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 7989589 2027-12-04 Drug substance 2021-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11661441 2033-01-13 U-4242 Drug substance 2023-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11661441 2033-01-13 U-3124 Drug substance 2023-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 10125171 2033-08-02 Drug substance 2021-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 10035822 2033-11-15 Drug substance 2021-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 10875893 2033-11-15 U-4242 Drug substance 2021-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 10875893 2033-11-15 U-3124 Drug substance 2021-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11292815 2033-11-15 U-3124 Drug substance, Drug product 2022-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11292815 2033-11-15 U-3354 Drug substance, Drug product 2022-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11292815 2033-11-15 U-4242 Drug substance, Drug product 2022-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11292815 2033-11-15 U-4243 Drug substance, Drug product 2022-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11040107 2038-04-09 U-3172 Drug product 2021-07-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11040107 2038-04-09 U-3174 Drug product 2021-07-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11040107 2038-04-09 U-3173 Drug product 2021-07-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11040107 2038-04-09 U-4241 Drug product 2021-07-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11844841 2038-12-09 U-4241 Drug product 2024-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11844841 2038-12-09 U-3172 Drug product 2024-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11844841 2038-12-09 U-3174 Drug product 2024-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 11844841 2038-12-09 U-3173 Drug product 2024-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 12290566 2038-12-14 U-4174 Drug product 2025-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 12290566 2038-12-14 U-4175 Drug product 2025-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 12290566 2038-12-14 U-4239 Drug product 2025-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 12290566 2038-12-14 U-4238 Drug product 2025-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215014-001 12290566 2038-12-14 U-4240 Drug product 2025-05-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215014-001 9169307 2027-11-18 U-4244 Drug substance 2021-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 9169307 2027-11-18 U-3123 Drug substance 2021-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 7888323 2027-12-04 Drug substance 2021-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 7989589 2027-12-04 Drug substance 2021-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 11661441 2033-01-13 U-4242 Drug substance 2023-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 11661441 2033-01-13 U-3124 Drug substance 2023-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 10125171 2033-08-02 Drug substance 2021-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 10035822 2033-11-15 Drug substance 2021-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 10875893 2033-11-15 U-4242 Drug substance 2021-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 10875893 2033-11-15 U-3124 Drug substance 2021-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 11292815 2033-11-15 U-3124 Drug substance, Drug product 2022-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 11292815 2033-11-15 U-3354 Drug substance, Drug product 2022-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215014-001 11292815 2033-11-15 U-4242 Drug substance, Drug product 2022-04-29 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 3 of 3 · 106 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Empaveli PEGCETACOPLAN Apellis Pharmaceuticals, Inc. c23d89e9-b00b-4520-e053-2995a90a95af 2026-08-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 215014 application number: NDA215014 ndc (product): 73606-010
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73606-010 Empaveli Pegcetacoplan Apellis Pharmaceuticals, Inc. NDA Current 73606-010 Empaveli Pegcetacoplan Apellis Pharmaceuticals, Inc. NDA Current 73606-010 Empaveli Pegcetacoplan Apellis Pharmaceuticals, Inc. NDA Current 73606-010 Empaveli Pegcetacoplan Apellis Pharmaceuticals, Inc. NDA Current