Application 209863

Type: NDA
Sponsor: ANTARES PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE	SOLUTION;SUBCUTANEOUS	50MG/0.5ML (50MG/0.5ML)	Yes	Yes
002	XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE	SOLUTION;SUBCUTANEOUS	75MG/0.5ML (75MG/0.5ML)	Yes	Yes
003	XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE	SOLUTION;SUBCUTANEOUS	100MG/0.5ML (100MG/0.5ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N209863-001	XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28
N209863-002	XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28
N209863-003	XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28

Orange Book patents#

Current patent rows page 1 of 1 · 69 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209863-001	10478560	2026-01-24		Drug product	2020-06-11
N209863-001	11446441	2026-01-24		Drug product	2022-10-07
N209863-001	8562564	2026-01-24		Drug product	2018-10-24
N209863-001	9180259	2026-01-24		Drug product	2018-10-24
N209863-001	9533102	2026-01-24		Drug product	2018-10-24
N209863-001	9629959	2026-01-24		Drug product	2018-10-24
N209863-001	8021335	2026-10-04		Drug product	2018-10-24
N209863-001	11497753	2030-03-19		Drug product	2022-12-14
N209863-001	10279131	2031-07-31		Drug product	2020-06-11
N209863-001	10357609	2031-08-21		Drug product	2020-06-11
N209863-001	10905827	2031-08-21		Drug product	2021-03-02
N209863-001	11446440	2031-08-21		Drug product	2022-10-07
N209863-001	10821072	2033-06-04	U-2418	Drug product	2020-11-23
N209863-001	11844804	2033-06-04	U-2418		2024-01-18
N209863-001	10881798	2034-02-11		Drug product	2021-02-04
N209863-001	11160751	2034-10-07	U-2418	Drug product	2022-01-06
N209863-001	10238662	2035-02-19	U-2418	Drug product	2020-06-11
N209863-001	10912782	2035-02-19	U-2418	Drug product	2021-03-02
N209863-001	11813435	2035-02-25		Drug product	2023-11-22
N209863-001	12629483	2035-08-07		Drug product	2026-06-04
N209863-001	11191908	2035-10-18		Drug product	2022-01-06
N209863-001	9744302	2035-11-19		Drug product	2018-10-24
N209863-001	9950125	2036-09-04	U-2418	Drug product	2018-10-24
N209863-002	10478560	2026-01-24		Drug product	2020-06-11
N209863-002	11446441	2026-01-24		Drug product	2022-10-07
N209863-002	8562564	2026-01-24		Drug product	2018-10-24
N209863-002	9180259	2026-01-24		Drug product	2018-10-24
N209863-002	9533102	2026-01-24		Drug product	2018-10-24
N209863-002	9629959	2026-01-24		Drug product	2018-10-24
N209863-002	8021335	2026-10-04		Drug product	2018-10-24
N209863-002	11497753	2030-03-19		Drug product	2022-12-14
N209863-002	10279131	2031-07-31		Drug product	2020-06-11
N209863-002	10357609	2031-08-21		Drug product	2020-06-11
N209863-002	10905827	2031-08-21		Drug product	2021-03-02
N209863-002	11446440	2031-08-21		Drug product	2022-10-07
N209863-002	10821072	2033-06-04	U-2418	Drug product	2020-11-23
N209863-002	11844804	2033-06-04	U-2418		2024-01-18
N209863-002	10881798	2034-02-11		Drug product	2021-02-04
N209863-002	11160751	2034-10-07	U-2418	Drug product	2022-01-06
N209863-002	10238662	2035-02-19	U-2418	Drug product	2020-06-11
N209863-002	10912782	2035-02-19	U-2418	Drug product	2021-03-02
N209863-002	11813435	2035-02-25		Drug product	2023-11-22
N209863-002	12629483	2035-08-07		Drug product	2026-06-04
N209863-002	11191908	2035-10-18		Drug product	2022-01-06
N209863-002	9744302	2035-11-19		Drug product	2018-10-24
N209863-002	9950125	2036-09-04	U-2418	Drug product	2018-10-24
N209863-003	10478560	2026-01-24		Drug product	2020-06-11
N209863-003	11446441	2026-01-24		Drug product	2022-10-07
N209863-003	8562564	2026-01-24		Drug product	2018-10-24
N209863-003	9180259	2026-01-24		Drug product	2018-10-24
N209863-003	9533102	2026-01-24		Drug product	2018-10-24
N209863-003	9629959	2026-01-24		Drug product	2018-10-24
N209863-003	8021335	2026-10-04		Drug product	2018-10-24
N209863-003	11497753	2030-03-19		Drug product	2022-12-14
N209863-003	10279131	2031-07-31		Drug product	2020-06-11
N209863-003	10357609	2031-08-21		Drug product	2020-06-11
N209863-003	10905827	2031-08-21		Drug product	2021-03-02
N209863-003	11446440	2031-08-21		Drug product	2022-10-07
N209863-003	10821072	2033-06-04	U-2418	Drug product	2020-11-23
N209863-003	11844804	2033-06-04	U-2418		2024-01-18
N209863-003	10881798	2034-02-11		Drug product	2021-02-04
N209863-003	11160751	2034-10-07	U-2418	Drug product	2022-01-06
N209863-003	10238662	2035-02-19	U-2418	Drug product	2020-06-11
N209863-003	10912782	2035-02-19	U-2418	Drug product	2021-03-02
N209863-003	11813435	2035-02-25		Drug product	2023-11-22
N209863-003	12629483	2035-08-07		Drug product	2026-06-04
N209863-003	11191908	2035-10-18		Drug product	2022-01-06
N209863-003	9744302	2035-11-19		Drug product	2018-10-24
N209863-003	9950125	2036-09-04	U-2418	Drug product	2018-10-24

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209863-002	XYOSTED (AUTOINJECTOR)	75MG/0.5ML (75MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209863-003	XYOSTED (AUTOINJECTOR)	100MG/0.5ML (100MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209863-001	XYOSTED (AUTOINJECTOR)	50MG/0.5ML (50MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2018-09-28	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 62 · 2,460 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209863-001	10478560	2026-01-24		Drug product	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	11446441	2026-01-24		Drug product	2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	8562564	2026-01-24		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	9180259	2026-01-24		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	9533102	2026-01-24		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	9629959	2026-01-24		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	8021335	2026-10-04		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	11497753	2030-03-19		Drug product	2022-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	10279131	2031-07-31		Drug product	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	10357609	2031-08-21		Drug product	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	10905827	2031-08-21		Drug product	2021-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	11446440	2031-08-21		Drug product	2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	10821072	2033-06-04	U-2418	Drug product	2020-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	11844804	2033-06-04	U-2418		2024-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	10881798	2034-02-11		Drug product	2021-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	11160751	2034-10-07	U-2418	Drug product	2022-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	10238662	2035-02-19	U-2418	Drug product	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	10912782	2035-02-19	U-2418	Drug product	2021-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	11813435	2035-02-25		Drug product	2023-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	12629483	2035-08-07		Drug product	2026-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	11191908	2035-10-18		Drug product	2022-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	9744302	2035-11-19		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-001	9950125	2036-09-04	U-2418	Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	10478560	2026-01-24		Drug product	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	11446441	2026-01-24		Drug product	2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	8562564	2026-01-24		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	9180259	2026-01-24		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	9533102	2026-01-24		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	9629959	2026-01-24		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	8021335	2026-10-04		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	11497753	2030-03-19		Drug product	2022-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	10279131	2031-07-31		Drug product	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	10357609	2031-08-21		Drug product	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	10905827	2031-08-21		Drug product	2021-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	11446440	2031-08-21		Drug product	2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	10821072	2033-06-04	U-2418	Drug product	2020-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	11844804	2033-06-04	U-2418		2024-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	10881798	2034-02-11		Drug product	2021-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	11160751	2034-10-07	U-2418	Drug product	2022-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209863-002	10238662	2035-02-19	U-2418	Drug product	2020-06-11	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209863-001	NP	2021-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209863-002	NP	2021-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209863-003	NP	2021-09-28	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209863-001	NP	2021-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209863-002	NP	2021-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209863-003	NP	2021-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209863-001	NP	2021-09-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209863-002	NP	2021-09-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209863-003	NP	2021-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209863-001	NP	2021-09-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209863-002	NP	2021-09-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209863-003	NP	2021-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209863-001	NP	2021-09-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209863-002	NP	2021-09-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209863-003	NP	2021-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209863-001	NP	2021-09-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209863-002	NP	2021-09-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209863-003	NP	2021-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209863-001	NP	2021-09-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209863-002	NP	2021-09-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209863-003	NP	2021-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209863-001	NP	2021-09-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209863-002	NP	2021-09-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209863-003	NP	2021-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209863-001	NP	2021-09-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209863-002	NP	2021-09-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209863-003	NP	2021-09-28	`ea99ee380514…`

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
XYOSTED	TESTOSTERONE ENANTHATE	Antares Pharma, Inc.	8a3d204c-be26-49e0-8599-0ac12a272e81	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209863 application number: NDA209863 ndc (product): 54436-250 ndc (product): 54436-275 ndc (product): 54436-200

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
54436-200	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-200	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-200	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-200	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-200	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-200	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-250	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-250	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-250	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-250	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-250	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-250	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-275	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-275	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-275	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-275	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-275	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current
54436-275	XYOSTED	testosterone enanthate	Antares Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82865	SUPPL	2025-07-15
82855	SUPPL	2025-07-14
82854	SUPPL	2025-07-11
60997	SUPPL	2019-11-20
60974	SUPPL	2019-11-20
58098	ORIG	2019-03-27
55880	ORIG	2018-10-11
55795	ORIG	2018-10-03
55794	ORIG	2018-10-03