Home Applications 214998 Application 214998
Type NDA
Sponsor MYOKARDIA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CAMZYOS MAVACAMTEN CAPSULE; ORAL 2.5MG No No 002 CAMZYOS MAVACAMTEN CAPSULE; ORAL 5MG No No 003 CAMZYOS MAVACAMTEN CAPSULE; ORAL 10MG No No 004 CAMZYOS MAVACAMTEN CAPSULE; ORAL 15MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214998-001 CAMZYOS MAVACAMTEN 2.5MG CAPSULE / ORAL RLD 2022-04-28 N214998-002 CAMZYOS MAVACAMTEN 5MG CAPSULE / ORAL RLD, RS 2022-04-28 N214998-003 CAMZYOS MAVACAMTEN 10MG CAPSULE / ORAL RLD 2022-04-28 N214998-004 CAMZYOS MAVACAMTEN 15MG CAPSULE / ORAL RLD 2022-04-28
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214998-001 9585883 2034-06-19 U-3373 2022-05-26 N214998-001 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 N214998-002 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 N214998-003 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 N214998-004 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 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.
Product history page 1 of 4 · 124 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 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214998-001 CAMZYOS 2.5MG CAPSULE / ORAL RLD 2022-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214998-002 CAMZYOS 5MG CAPSULE / ORAL RLD, RS 2022-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214998-003 CAMZYOS 10MG CAPSULE / ORAL RLD 2022-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214998-004 CAMZYOS 15MG CAPSULE / ORAL RLD 2022-04-28 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 7 · 248 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 N214998-001 9585883 2034-06-19 U-3373 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-001 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-002 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-003 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214998-004 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214998-001 9585883 2034-06-19 U-3373 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-001 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-002 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-003 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214998-004 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214998-001 9585883 2034-06-19 U-3373 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-001 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-002 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-003 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214998-004 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-001 9585883 2034-06-19 U-3373 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-001 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-002 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-003 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214998-004 RE50050 2036-04-28 Drug substance, Drug product 2024-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214998-001 9585883 2034-06-19 U-3373 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-001 RE50050 2034-06-19 Drug substance, Drug product 2024-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-002 9585883 2034-06-19 U-3373 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-002 RE50050 2034-06-19 Drug substance, Drug product 2024-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-003 9585883 2034-06-19 U-3373 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-003 RE50050 2034-06-19 Drug substance, Drug product 2024-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-004 9585883 2034-06-19 U-3373 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214998-004 RE50050 2034-06-19 Drug substance, Drug product 2024-08-20 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 2 of 8 · 312 observed states.
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 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73625-111 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-111 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-111 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-111 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-112 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-112 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-112 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-112 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-113 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-113 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-113 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-113 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-114 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-114 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-114 CAMZYOS mavacamten Myokardia, Inc. NDA Current 73625-114 CAMZYOS mavacamten Myokardia, Inc. NDA Current