Application 021463

Type: NDA
Sponsor: ENDO PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FORTESTA	TESTOSTERONE	GEL, METERED;TRANSDERMAL	10MG/0.5GM ACTUATION	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
N021463-001	FORTESTA	TESTOSTERONE	10MG/0.5GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2010-12-29

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021463-001	FORTESTA	10MG/0.5GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021463-001	FORTESTA	10MG/0.5GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021463-001	FORTESTA	10MG/0.5GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021463-001	FORTESTA	10MG/0.5GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021463-001	FORTESTA	10MG/0.5GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021463-001	FORTESTA	10MG/0.5GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021463-001	FORTESTA	10MG/0.5GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL		RLD	2010-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021463-001	FORTESTA	10MG/0.5GM ACTUATION	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2010-12-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021463-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021463-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021463-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021463-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021463-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021463-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021463-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021463-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021463-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021463-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021463-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021463-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021463-001	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N021463-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021463-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021463-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021463-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021463-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021463-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021463-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021463-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021463-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021463-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021463-001	AB	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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Testosterone	TESTOSTERONE	Encube Ethicals, Inc.	ca5d4865-356b-45e7-b603-fe299e450abc	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
TESTOSTERONE	TESTOSTERONE	Encube Ethicals, Inc.	44a04f66-fd2a-45c7-934e-8f14c023ce14	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Northstar Rx LLC	65981b8a-d5cc-1964-7eac-a07f032c2571	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Xiromed, LLC	28e8d504-5073-1d78-f351-bcb7c5188ee6	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Lupin Pharmaceuticals, Inc.	29c8846f-121c-4958-9e03-3bd271c21558	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Lupin Pharmaceuticals, Inc.	61387416-510d-40c5-9e2d-24bfb7f56d08	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Bryant Ranch Prepack	c6c0a39e-0e75-4356-a052-c26c30c76b26	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Actavis Pharma, Inc.	5834d34f-839d-412c-b74c-da1dad2cfa88	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Actavis Pharma, Inc.	e18b4495-c5a3-4a7f-9636-179320784381	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Bryant Ranch Prepack	6c7d2dec-6492-4d53-b110-61ffeae9ee61	2025-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
testosterone	TESTOSTERONE	Northstar Rx LLC	2d55b825-8eab-4091-bdf2-9c52d111b8eb	2025-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
testosterone	TESTOSTERONE	Padagis Israel Pharmaceuticals Ltd	54fcdcb9-fb0e-4164-9e51-f2a5feae3217	2025-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Strides Pharma Science Limited	ee54c393-bcfe-4a52-b7b3-1da8750f35d9	2025-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Actavis Pharma, Inc.	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
testosterone	TESTOSTERONE	Bryant Ranch Prepack	9e10a37a-9c40-456b-a362-2fa8eae31e84	2025-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Natesto nasal gel	TESTOSTERONE	Acerus Pharmaceuticals Corporation	dea6bed1-eaca-11e3-ac10-0800200c9a66	2025-07-22	Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testopel	TESTOSTERONE	Endo USA, Inc.	03b9c0b1-5884-11e4-8ed6-0800200c9a66	2025-07-17	Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Testim	TESTOSTERONE	Endo USA, Inc.	9f2aae1f-898d-4955-be31-678e0cf85395	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
Vogelxo	TESTOSTERONE	Upsher-Smith Laboratories, LLC	2dd150f6-cdfd-4d51-8888-12b288f26262	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE
TESTOSTERONE	TESTOSTERONE	Alembic Pharmaceuticals Inc.	e39289aa-681c-47ec-9461-52e7f17e5d71	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TESTOSTERONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-7831	Testosterone	Testosterone	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
0603-7831	Testosterone	Testosterone	Par Pharmaceutical	NDA AUTHORIZED GENERIC	Current
0603-7831	Testosterone	Testosterone	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
0603-7831	Testosterone	Testosterone	Par Pharmaceutical	NDA AUTHORIZED GENERIC	Current
63481-183	FORTESTA	testosterone	Endo Pharmaceuticals, Inc.	NDA	Current
63481-183	FORTESTA	testosterone	Endo Pharmaceuticals Inc.	NDA	Current
63481-183	FORTESTA	testosterone	Endo Pharmaceuticals, Inc.	NDA	Current
63481-183	FORTESTA	testosterone	Endo Pharmaceuticals Inc.	NDA	Current
63481-183	FORTESTA	testosterone	Endo Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82870	SUPPL	2025-07-15
82842	SUPPL	2025-07-14
82841	SUPPL	2025-07-14
63779	SUPPL	2020-07-02
63778	SUPPL	2020-07-02
63766	SUPPL	2020-07-01
62153	SUPPL	2020-03-17
62144	SUPPL	2020-03-16
58914	SUPPL	2019-06-03
58744	SUPPL	2019-05-16
58743	SUPPL	2019-05-16
58659	SUPPL	2019-05-13
45761	SUPPL	2016-11-01
45754	SUPPL	2016-11-01
45674	SUPPL	2016-10-27
37008	SUPPL	2015-05-13
27867	SUPPL	2015-05-13
27866	SUPPL	2014-08-01
27865	SUPPL	2014-06-23
15536	SUPPL	2014-06-23
37007	SUPPL	2014-03-25
27864	SUPPL	2014-03-25
27863	SUPPL	2013-09-11
15535	SUPPL	2013-09-11
24202	ORIG	2011-09-16
21673	ORIG	2011-09-16
23268	ORIG	2011-01-13
37006	ORIG	2011-01-11
44478	ORIG	2011-01-07
5457	ORIG	2011-01-07