Application 091244

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

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
A091244-001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO		2012-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091244-001	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	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091244-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2012-05-01	`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	A091244-001	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091244-001	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091244-001	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091244-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091244-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091244-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091244-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091244-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091244-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091244-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091244-001	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091244-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091244-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091244-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091244-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091244-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091244-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091244-001	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091244-001	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091244-001	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091244-001	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091244-001	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091244-001	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091244-001	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091244-001	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091244-001	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091244-001	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091244-001	AO	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091244-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091244-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091244-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091244-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091244-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091244-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091244-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091244-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091244-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091244-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091244-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091244-001	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Testosterone Cypionate	TESTOSTERONE CYPIONATE	ASCLEMED USA INC.	4efcb0be-a19b-4c6b-8a42-cd52a40d095b	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	ad65b1ec-433e-4524-924e-ebad09762126	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244 ndc (product): 63629-8705
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	327b4357-6948-4cd6-ad6c-e463ab8600ad	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Cipla USA Inc.	b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c478	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244 ndc (product): 69097-802
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Hikma Pharmaceuticals USA Inc.	f60c5520-b336-44a2-95d5-f274939fa595	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244 ndc (product): 0143-9659 ndc (product): 0143-9726
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Hikma Pharmaceuticals USA Inc.	5ca67491-4b30-4a47-af0a-be250215d1f0	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244 ndc (product): 0143-9005
Testosterone Cypionate	TESTOSTERONE CYPIONATE	A-S Medication Solutions	47df0787-af81-43ca-bd67-1b5d127ff3c3	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244 ndc (product): 50090-4920
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	9d0a1923-be39-41d9-8183-706b227f615c	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	8699c6cb-fede-43ea-ad5e-817700fa7a82	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	3b0c61de-8cfa-4f76-b07c-0d3b7704b642	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244 ndc (product): 63629-8706
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Padagis US LLC	e3e2da65-4b2a-4210-a6ff-cc08c8567381	2021-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244 ndc (product): 0574-0827
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Proficient Rx LP	6bb7d3cc-2b5a-4a48-858e-5421c68b6989	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244 ndc (product): 63187-647
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Proficient Rx LP	2db0a398-5512-431c-a952-b0290d4fe2d9	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091244 application number: ANDA091244 ndc (product): 71205-289

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9005	Testosterone Cypionate	Testosterone Cypionate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9659	Testosterone Cypionate	Testosterone Cypionate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9659	Testosterone Cypionate	Testosterone Cypionate	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9726	Testosterone Cypionate	Testosterone Cypionate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9726	Testosterone Cypionate	Testosterone Cypionate	West-Ward Pharmaceuticals Corp	ANDA	Current
0574-0827	Testosterone Cypionate	Testosterone Cypionate	Padagis US LLC	ANDA	Current
0574-0827	Testosterone Cypionate	Testosterone Cypionate	Paddock Laboratories, LLC	ANDA	Current
0574-0827	Testosterone Cypionate	Testosterone Cypionate	Paddock Laboratories, LLC	ANDA	Current
0591-4128	Testosterone Cypionate	Testosterone Cypionate	Actavis Pharma, Inc.	ANDA	Current
0591-4128	Testosterone Cypionate	Testosterone Cypionate	Actavis Pharma, Inc.	ANDA	Current
0591-4128	Testosterone Cypionate	Testosterone Cypionate	Actavis Pharma, Inc.	ANDA	Current
0591-4128	Testosterone Cypionate	Testosterone Cypionate	Actavis Pharma, Inc.	ANDA	Current
50090-0330	Testosterone Cypionate	Testosterone Cypionate	A-S Medication Solutions	ANDA	Current
50090-0330	Testosterone Cypionate	Testosterone Cypionate	A-S Medication Solutions	ANDA	Current
50090-4920	Testosterone Cypionate	Testosterone Cypionate	A-S Medication Solutions	ANDA	Current
50090-4921	Testosterone Cypionate	Testosterone Cypionate	A-S Medication Solutions	ANDA	Current
63187-647	Testosterone Cypionate	Testosterone Cypionate	Proficient Rx LP	ANDA	Current
63187-647	Testosterone Cypionate	Testosterone Cypionate	Proficient Rx LP	ANDA	Current
63629-8705	Testosterone Cypionate	Testosterone Cypionate	Bryant Ranch Prepack	ANDA	Current
63629-8705	Testosterone Cypionate	Testosterone Cypionate	Bryant Ranch Prepack	ANDA	Current
63629-8705	Testosterone Cypionate	Testosterone Cypionate	Bryant Ranch Prepack	ANDA	Current
63629-8705	Testosterone Cypionate	Testosterone Cypionate	Bryant Ranch Prepack	ANDA	Current
63629-8706	Testosterone Cypionate	Testosterone Cypionate	Bryant Ranch Prepack	ANDA	Current
63629-8706	Testosterone Cypionate	Testosterone Cypionate	Bryant Ranch Prepack	ANDA	Current
63629-8706	Testosterone Cypionate	Testosterone Cypionate	Bryant Ranch Prepack	ANDA	Current
69097-802	Testosterone Cypionate	Testosterone Cypionate	Cipla USA Inc.	ANDA	Current
69097-802	Testosterone Cypionate	Testosterone Cypionate	Cipla USA Inc.	ANDA	Current
71205-289	Testosterone Cypionate	Testosterone Cypionate	Proficient Rx LP	ANDA	Current
71205-289	Testosterone Cypionate	Testosterone Cypionate	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53974	ORIG	2018-05-01
43246	ORIG	2013-01-22