Application 215351

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	INJECTABLE;INJECTION	100MG/ML	No	No
002	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	INJECTABLE;INJECTION	200MG/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215351-001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO		2023-04-13
A215351-002	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO		2023-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A215351-001	AO
A215351-002	AO

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 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215351-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215351-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2023-04-13	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215351-001	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215351-002	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215351-001	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215351-002	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215351-001	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215351-002	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215351-001	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215351-002	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215351-001	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215351-002	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215351-001	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215351-002	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215351-001	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215351-002	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215351-001	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215351-002	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215351-001	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215351-002	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215351-001	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215351-002	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215351-001	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215351-002	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215351-001	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215351-002	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215351-001	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215351-002	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215351-001	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215351-002	AO	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215351-001	AO	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215351-002	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215351-001	AO	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215351-002	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215351-001	AO	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215351-002	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215351-001	AO	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215351-002	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215351-001	AO	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215351-002	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215351-001	AO	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215351-002	AO	1	`a67488948f0b…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
testosterone cypionate	TESTOSTERONE CYPIONATE	A-S Medication Solutions	7df45a8d-7d6b-4776-85e3-529527574a4f	2026-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215351 application number: ANDA215351
testosterone cypionate	TESTOSTERONE CYPIONATE	NorthStar Rx LLC	9ced69c7-cd37-efb6-1bf9-e21c01e56f5b	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215351 application number: ANDA215351
testosterone cypionate	TESTOSTERONE CYPIONATE	Xiromed LLC	cab949ca-fde9-c5a9-5561-21e98d86d078	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215351 application number: ANDA215351
testosterone cypionate	TESTOSTERONE CYPIONATE	A-S Medication Solutions	e9d48af3-9514-4dc5-972c-0c1f2547e5c6	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215351 application number: ANDA215351