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 1 of 8 · 312 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.
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