Application 207742

Type: ANDA
Sponsor: AM REGENT

Application Products#

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207742-001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO		2017-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207742-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207742-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2017-06-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207742-001	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207742-001	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207742-001	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207742-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207742-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207742-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207742-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207742-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207742-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207742-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207742-001	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207742-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207742-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207742-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207742-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207742-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207742-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207742-001	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207742-001	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207742-001	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207742-001	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207742-001	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207742-001	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207742-001	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207742-001	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207742-001	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207742-001	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207742-001	AO	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207742-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207742-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207742-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207742-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207742-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207742-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207742-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207742-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207742-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207742-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207742-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207742-001	AO	1	`e64feba35796…`

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	Alvogen Inc.	ed65346b-31bc-f872-516d-78d5ab70229e	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207742 application number: ANDA207742 ndc (product): 47781-910 ndc (product): 47781-911
testosterone cypionate	TESTOSTERONE CYPIONATE	NuCare Pharmaceuticals, Inc.	346604c7-22d0-60c5-e063-6394a90abf0b	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207742 application number: ANDA207742
testosterone cypionate	TESTOSTERONE CYPIONATE	NuCare Pharmaceuticals,Inc.	335ff614-15ec-0792-e063-6294a90a2f08	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207742 application number: ANDA207742
testosterone cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	ffb1ae64-9026-44c9-83a0-32058957ecc9	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207742 application number: ANDA207742

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-1830	Testosterone Cypionate	Testosterone Cypionate	American Regent, Inc.	ANDA	Current
0517-1830	Testosterone Cypionate	Testosterone Cypionate	American Regent, Inc.	ANDA	Current
47781-910	testosterone cypionate	testosterone cypionate	Alvogen Inc.	ANDA	Current
47781-911	testosterone cypionate	testosterone cypionate	Alvogen Inc.	ANDA	Current
64980-467	Testosterone Cypionate	Testosterone Cypionate	Rising Pharmaceuticals, I	ANDA	Current
64980-467	Testosterone Cypionate	Testosterone Cypionate	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-467	Testosterone Cypionate	Testosterone Cypionate	Rising Pharmaceuticals, Inc.	ANDA	Current