Application 086030

Type: ANDA
Sponsor: WATSON PHARMS INC

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
A086030-001	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982

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	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086030-001	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE / INJECTION	AO	Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086030-001	AO	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086030-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086030-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086030-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086030-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086030-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086030-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086030-001	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086030-001	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086030-001	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086030-001	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086030-001	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086030-001	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086030-001	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086030-001	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086030-001	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086030-001	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086030-001	AO	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086030-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086030-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086030-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086030-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086030-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086030-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086030-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086030-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086030-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086030-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086030-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086030-001	AO	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086030-001	AO	1	`cb3db0bc1861…`

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 3 · 42 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	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	ad65b1ec-433e-4524-924e-ebad09762126	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	327b4357-6948-4cd6-ad6c-e463ab8600ad	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	A-S Medication Solutions	2321a581-2e33-4233-a1d4-0711b90e3c57	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
testosterone cypionate	TESTOSTERONE CYPIONATE	A-S Medication Solutions	7df45a8d-7d6b-4776-85e3-529527574a4f	2026-01-24	Warnings, Adverse reactions	Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	A-S Medication Solutions	5fb0c403-3065-498e-b910-c5988269301a	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	REMEDYREPACK INC.	40a332e3-9c64-4595-91c3-dfef24f3d3bb	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: TESTOSTERONE CYPIONATE generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Bryant Ranch Prepack	1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
testosterone cypionate	TESTOSTERONE CYPIONATE	Alvogen Inc.	ed65346b-31bc-f872-516d-78d5ab70229e	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE
Depo-Testosterone	TESTOSTERONE CYPIONATE	Pharmacia & Upjohn Company LLC	cfbb53d4-b868-4a28-8436-f9112eb01c39	2025-09-29	Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE CYPIONATE
Depo-Testosterone	TESTOSTERONE CYPIONATE	Asclemed USA, Inc.	2f72be32-ede6-44d9-88a0-0653b53a3e47	2025-08-27	Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Hospira, Inc.	6909596e-4bf7-4e11-8029-b89740a30aec	2025-08-22	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
testosterone cypionate	TESTOSTERONE CYPIONATE	NorthStar Rx LLC	9ced69c7-cd37-efb6-1bf9-e21c01e56f5b	2025-08-05	Warnings, Adverse reactions	Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE
testosterone cypionate	TESTOSTERONE CYPIONATE	Xiromed LLC	cab949ca-fde9-c5a9-5561-21e98d86d078	2025-08-05	Warnings, Adverse reactions	Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE
AZMIRO	TESTOSTERONE CYPIONATE	Azurity Pharmaceuticals, Inc.	235b5625-570d-3fba-e063-6394a90aa2d1	2025-07-25	Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Wilshire Pharmaceuticals	58ff6e0d-cc0a-4455-8254-d883d26a3b6d	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Depo-Testosterone	TESTOSTERONE CYPIONATE	Pharmacia & Upjohn Company LLC	735b5bf3-4464-412c-a072-1bd02f2e5380	2025-07-14	Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE CYPIONATE
testosterone cypionate	TESTOSTERONE CYPIONATE	A-S Medication Solutions	e9d48af3-9514-4dc5-972c-0c1f2547e5c6	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: testosterone cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Cipla USA Inc.	b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c478	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE
Testosterone Cypionate	TESTOSTERONE CYPIONATE	Padagis US LLC	4195516a-c8e6-457c-b805-43c9a3ca8b77	2025-06-03	Warnings, Adverse reactions	Name fallback brand name: Testosterone Cypionate generic name: TESTOSTERONE CYPIONATE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55045-2092	Testosterone Cypionate	Testosterone Cypionate	Dispensing Solutions, Inc.	ANDA	Current