Application 090387

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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 43.

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
A090387-001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO		2010-07-15
A090387-002	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO		2010-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090387-001	AO
A090387-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090387-001	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090387-002	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	2010-07-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090387-001	AO	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090387-002	AO	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090387-001	AO	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090387-002	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090387-001	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090387-002	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090387-001	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090387-002	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090387-001	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090387-002	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090387-001	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090387-002	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090387-001	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090387-002	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090387-001	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090387-002	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090387-001	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090387-002	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090387-001	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090387-002	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090387-001	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090387-002	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090387-001	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090387-002	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090387-001	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090387-002	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090387-001	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090387-002	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090387-001	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090387-002	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090387-001	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090387-002	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090387-001	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090387-002	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090387-001	AO	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090387-002	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090387-001	AO	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090387-002	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090387-001	AO	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090387-002	AO	1	`74a2ff9319b5…`

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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Hikma Pharmaceuticals USA Inc.	f60c5520-b336-44a2-95d5-f274939fa595	2025-06-01	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Hikma Pharmaceuticals USA Inc.	5ca67491-4b30-4a47-af0a-be250215d1f0	2025-06-01	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Sun Pharmaceutical Industries, Inc.	3653a602-4551-4e6c-84a7-31861f5dc482	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	Cipla USA Inc.	78d55bad-4a5b-4e21-aeb8-a4c6346208be	2025-05-09	Warnings, Adverse reactions	Name fallback brand name: TESTOSTERONE CYPIONATE generic name: TESTOSTERONE CYPIONATE
testosterone cypionate	TESTOSTERONE CYPIONATE	NuCare Pharmaceuticals, Inc.	346604c7-22d0-60c5-e063-6394a90abf0b	2025-05-05	Warnings, Adverse reactions	Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE
testosterone cypionate	TESTOSTERONE CYPIONATE	NuCare Pharmaceuticals,Inc.	335ff614-15ec-0792-e063-6294a90a2f08	2025-04-22	Warnings, Adverse reactions	Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	NuCare pgarmaceuticals,Inc.	30b453b9-25ef-8262-e063-6394a90a24c2	2025-03-19	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	5a0bba6a-e8da-4b12-af63-eb27b1cca9e6	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	2eb9e2a9-75ec-4a5d-8131-0076c50708bb	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	72cc2d2d-7807-46a6-a0ac-790a1f8dcaac	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	b116d834-51f1-4b92-8e1e-a51dbd883c1f	2024-07-30	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	A-S Medication Solutions	47df0787-af81-43ca-bd67-1b5d127ff3c3	2024-07-30	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
testosterone cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	ffb1ae64-9026-44c9-83a0-32058957ecc9	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	9d0a1923-be39-41d9-8183-706b227f615c	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	8699c6cb-fede-43ea-ad5e-817700fa7a82	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	54aee197-7c9c-479f-8a4d-a8d4d31f40c1	2023-11-20	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	3b0c61de-8cfa-4f76-b07c-0d3b7704b642	2023-07-17	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	66d4ae28-97c2-42cc-ab5a-a765a623c944	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Padagis US LLC	e3e2da65-4b2a-4210-a6ff-cc08c8567381	2021-09-10	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Proficient Rx LP	6bb7d3cc-2b5a-4a48-858e-5421c68b6989	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53973	ORIG	2018-05-01