Application 022219

Type: NDA
Sponsor: ENDO PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AVEED	TESTOSTERONE UNDECANOATE	INJECTABLE;INTRAMUSCULAR	750MG/3ML (250MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N022219-001	AVEED	TESTOSTERONE UNDECANOATE	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR		RLD, RS	2014-03-05

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022219-001	7718640	2027-03-14		Drug product
N022219-001	8338395	2027-05-08	U-1500

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022219-001	AVEED	750MG/3ML (250MG/ML)	INJECTABLE / INTRAMUSCULAR	RLD, RS	2014-03-05	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022219-001	7718640	2027-03-14		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022219-001	8338395	2027-05-08	U-1500		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022219-001	7718640	2027-03-14		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022219-001	8338395	2027-05-08	U-1500		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022219-001	7718640	2027-03-14		Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022219-001	8338395	2027-05-08	U-1500		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022219-001	7718640	2027-03-14		Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022219-001	8338395	2027-05-08	U-1500		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022219-001	7718640	2027-03-14		Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022219-001	8338395	2027-05-08	U-1500		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022219-001	7718640	2027-03-14		Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022219-001	8338395	2027-05-08	U-1500		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022219-001	7718640	2027-03-14		Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022219-001	8338395	2027-05-08	U-1500		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022219-001	7718640	2027-03-14		Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022219-001	8338395	2027-05-08	U-1500		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022219-001	7718640	2027-03-14		Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022219-001	8338395	2027-05-08	U-1500		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022219-001	7718640	2027-03-14		Drug product	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022219-001	8338395	2027-05-08	U-1500		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022219-001	7718640	2027-03-14		Drug product	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022219-001	8338395	2027-05-08	U-1500		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022219-001	7718640	2027-03-14		Drug product	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022219-001	8338395	2027-05-08	U-1500		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022219-001	7718640	2027-03-14		Drug product	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022219-001	8338395	2027-05-08	U-1500		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022219-001	7718640	2027-03-14		Drug product	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022219-001	8338395	2027-05-08	U-1500		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022219-001	7718640	2027-03-14		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022219-001	8338395	2027-05-08	U-1500		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022219-001	7718640	2027-03-14		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022219-001	8338395	2027-05-08	U-1500		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022219-001	7718640	2027-03-14		Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022219-001	8338395	2027-05-08	U-1500		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022219-001	8338395	2026-02-27	U-1500		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022219-001	7718640	2027-03-14		Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022219-001	7718640	2027-03-14		Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022219-001	8338395	2027-05-08	U-1500		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022219-001	7718640	2027-03-14		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022219-001	8338395	2027-05-08	U-1500		`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aveed	TESTOSTERONE UNDECANOATE	Endo USA, Inc.	f80f025b-17d8-40af-8739-20ce07902045	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022219 application number: NDA022219 ndc (product): 67979-511

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
67979-511	Aveed	testosterone undecanoate	Endo Pharmaceuticals Inc.	NDA	Current
67979-511	Aveed	testosterone undecanoate	Endo Pharmaceuticals Inc.	NDA	Current
67979-511	Aveed	testosterone undecanoate	Endo Pharmaceuticals Inc.	NDA	Current
67979-511	Aveed	testosterone undecanoate	Endo Pharmaceuticals Inc.	NDA	Current
67979-511	Aveed	testosterone undecanoate	Endo Pharmaceuticals Inc.	NDA	Current
67979-511	Aveed	testosterone undecanoate	Endo Pharmaceuticals Solutions Inc.	NDA	Current
67979-511	Aveed	testosterone undecanoate	Endo Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82871	SUPPL	2025-07-15
82838	SUPPL	2025-07-14
79844	SUPPL	2024-10-09
71166	SUPPL	2022-05-31
68398	SUPPL	2021-08-18
68388	SUPPL	2021-08-17
67983	SUPPL	2021-06-30
63777	SUPPL	2020-07-02
63776	SUPPL	2020-07-02
63767	SUPPL	2020-07-01
62154	SUPPL	2020-03-17
62145	SUPPL	2020-03-16
60741	SUPPL	2019-10-31
60740	SUPPL	2019-10-31
60739	SUPPL	2019-10-31
56938	SUPPL	2018-12-21
55456	SUPPL	2018-09-12
52747	ORIG	2018-02-28
51908	SUPPL	2018-01-26
51904	SUPPL	2018-01-26
46131	SUPPL	2016-12-13
45746	SUPPL	2016-11-01
45676	SUPPL	2016-10-27
42454	ORIG	2016-03-28
38401	SUPPL	2015-05-13
7067	SUPPL	2015-05-13
38400	SUPPL	2015-03-05
29420	SUPPL	2015-03-04
38399	SUPPL	2014-06-23
7066	SUPPL	2014-06-23
24019	ORIG	2014-03-13
17098	ORIG	2014-03-06
7065	ORIG	2014-03-06