Application 202763

Type: NDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	25MG/2.5GM PACKET	No	No
002	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	50MG/5GM PACKET	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N202763-001	TESTOSTERONE	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL			2012-02-14
N202763-002	TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL			2012-02-14

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202763-001	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202763-002	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2012-02-14	`bb7c543d1eb4…`

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 brand name: Testosterone generic name: TESTOSTERONE
TESTOSTERONE	TESTOSTERONE	Encube Ethicals, Inc.	44a04f66-fd2a-45c7-934e-8f14c023ce14	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TESTOSTERONE generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Northstar Rx LLC	65981b8a-d5cc-1964-7eac-a07f032c2571	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Xiromed, LLC	28e8d504-5073-1d78-f351-bcb7c5188ee6	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Lupin Pharmaceuticals, Inc.	29c8846f-121c-4958-9e03-3bd271c21558	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Lupin Pharmaceuticals, Inc.	61387416-510d-40c5-9e2d-24bfb7f56d08	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Bryant Ranch Prepack	c6c0a39e-0e75-4356-a052-c26c30c76b26	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Actavis Pharma, Inc.	5834d34f-839d-412c-b74c-da1dad2cfa88	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Actavis Pharma, Inc.	e18b4495-c5a3-4a7f-9636-179320784381	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Bryant Ranch Prepack	6c7d2dec-6492-4d53-b110-61ffeae9ee61	2025-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
testosterone	TESTOSTERONE	Northstar Rx LLC	2d55b825-8eab-4091-bdf2-9c52d111b8eb	2025-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: testosterone generic name: TESTOSTERONE
testosterone	TESTOSTERONE	Padagis Israel Pharmaceuticals Ltd	54fcdcb9-fb0e-4164-9e51-f2a5feae3217	2025-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Strides Pharma Science Limited	ee54c393-bcfe-4a52-b7b3-1da8750f35d9	2025-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Actavis Pharma, Inc.	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
testosterone	TESTOSTERONE	Bryant Ranch Prepack	9e10a37a-9c40-456b-a362-2fa8eae31e84	2025-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: testosterone 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 brand name: TESTOSTERONE generic name: TESTOSTERONE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45748	SUPPL	2016-11-01
45679	SUPPL	2016-10-27
40212	SUPPL	2015-05-13
10103	SUPPL	2015-05-13
40210	SUPPL	2014-07-24
32297	SUPPL	2014-07-24
40211	SUPPL	2014-06-23
10102	SUPPL	2014-06-23
44864	ORIG	2012-04-17
43412	ORIG	2012-04-17
24104	ORIG	2012-03-06
43957	ORIG	2012-02-17
19373	ORIG	2012-02-17
10101	ORIG	2012-02-17