Application 009165

Type: NDA
Sponsor: ENDO PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N009165-001	DELATESTRYL	TESTOSTERONE ENANTHATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982
N009165-003	DELATESTRYL	TESTOSTERONE ENANTHATE	200MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009165-001	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009165-003	DELATESTRYL	200MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`3a93d1ddd44b…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TESTOSTERONE ENANTHATE	TESTOSTERONE ENANTHATE	Eugia US LLC	82a98132-9d5f-40a5-8c4f-f52f2a5de60e	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE ENANTHATE
TESTOSTERONE ENANTHATE	TESTOSTERONE ENANTHATE	Hikma Pharmaceuticals USA Inc.	e89d6458-428c-4256-97a3-f1fa851293c1	2026-05-08	Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE ENANTHATE
XYOSTED	TESTOSTERONE ENANTHATE	Antares Pharma, Inc.	8a3d204c-be26-49e0-8599-0ac12a272e81	2025-07-01	Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE ENANTHATE

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
45745	SUPPL	2016-11-01
45670	SUPPL	2016-10-27
32986	SUPPL	2015-05-13
11863	SUPPL	2015-05-13
10718	SUPPL	2014-06-23
126	SUPPL	2014-06-23
125	SUPPL	2007-07-30
32985	SUPPL	2007-07-27
32984	SUPPL	2007-03-15
11862	SUPPL	2007-03-15