Application 213953

Type: NDA
Sponsor: MARIUS PHARMACEUTICALS, LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KYZATREX	TESTOSTERONE UNDECANOATE	CAPSULE; ORAL	100MG	No	No
002	KYZATREX	TESTOSTERONE UNDECANOATE	CAPSULE; ORAL	150MG	No	No
003	KYZATREX	TESTOSTERONE UNDECANOATE	CAPSULE; ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N213953-001	KYZATREX	TESTOSTERONE UNDECANOATE	100MG	CAPSULE / ORAL	RLD	2022-07-27
N213953-002	KYZATREX	TESTOSTERONE UNDECANOATE	150MG	CAPSULE / ORAL	RLD	2022-07-27
N213953-003	KYZATREX	TESTOSTERONE UNDECANOATE	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213953-001	10576089	2030-12-31	U-2506	Drug product	2022-08-26
N213953-001	10576090	2030-12-31		Drug product	2022-08-26
N213953-001	11590146	2030-12-31		Drug product	2023-05-31
N213953-001	11617758	2033-03-15	U-2506	Drug product	2023-05-31
N213953-001	12357643	2033-03-15	U-2506	Drug product	2025-08-13
N213953-001	12403146	2041-03-29	U-2506	Drug product	2025-10-03
N213953-002	10576089	2030-12-31	U-2506	Drug product	2022-08-26
N213953-002	10576090	2030-12-31		Drug product	2022-08-26
N213953-002	11590146	2030-12-31		Drug product	2023-05-31
N213953-002	11617758	2033-03-15	U-2506	Drug product	2023-05-31
N213953-002	12357643	2033-03-15	U-2506	Drug product	2025-08-13
N213953-002	12403146	2041-03-29	U-2506	Drug product	2025-10-03
N213953-003	10576089	2030-12-31	U-2506	Drug product	2022-08-26
N213953-003	10576090	2030-12-31		Drug product	2022-08-26
N213953-003	11590146	2030-12-31		Drug product	2023-05-31
N213953-003	11617758	2033-03-15	U-2506	Drug product	2023-05-31
N213953-003	12357643	2033-03-15	U-2506	Drug product	2025-08-13
N213953-003	12403146	2041-03-29	U-2506	Drug product	2025-10-03

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 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 312 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213953-001	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-001	10576090	2030-12-31		Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-001	11590146	2030-12-31		Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-001	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-001	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-001	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	10576090	2030-12-31		Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	11590146	2030-12-31		Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	10576090	2030-12-31		Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	11590146	2030-12-31		Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	10576090	2030-12-31		Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	11590146	2030-12-31		Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	10576090	2030-12-31		Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	11590146	2030-12-31		Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	10576090	2030-12-31		Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	11590146	2030-12-31		Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213953-001	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-001	10576090	2030-12-31		Drug product	2022-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-001	11590146	2030-12-31		Drug product	2023-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-001	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	NP	2025-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	NP	2025-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	NP	2025-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213953-001	NP	2025-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-002	NP	2025-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-003	NP	2025-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-001	NP	2025-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-002	NP	2025-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-003	NP	2025-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-001	NP	2025-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-002	NP	2025-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-003	NP	2025-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-001	NP	2025-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-002	NP	2025-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-003	NP	2025-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-001	NP	2025-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-002	NP	2025-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-003	NP	2025-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-001	NP	2025-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-002	NP	2025-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-003	NP	2025-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-001	NP	2025-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-002	NP	2025-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-003	NP	2025-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213953-001	NP	2025-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213953-002	NP	2025-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213953-003	NP	2025-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-001	NP	2025-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-002	NP	2025-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-003	NP	2025-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-001	NP	2025-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-002	NP	2025-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-003	NP	2025-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-001	NP	2025-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-002	NP	2025-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-003	NP	2025-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213953-001	NP	2025-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213953-002	NP	2025-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213953-003	NP	2025-07-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213953-001	NP	2025-07-27	`6a51e52b5d6a…`

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
Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	7f7167a7-2a25-47e2-acf5-33f499fce971	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213953 application number: NDA213953 ndc (product): 80603-103 ndc (product): 80603-101 ndc (product): 80603-105

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
80603-101	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-101	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-101	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-101	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-101	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-101	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-103	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-103	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-103	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-103	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-103	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-103	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-105	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-105	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-105	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-105	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-105	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current
80603-105	Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82866	SUPPL	2025-07-15
82846	SUPPL	2025-07-14
82845	SUPPL	2025-07-14
72987	ORIG	2022-12-21
71659	ORIG	2022-07-28
71654	ORIG	2022-07-28