Application 203098

Type: NDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTOSTERONE	TESTOSTERONE	GEL, METERED;TRANSDERMAL	12.5MG/1.25GM ACTUATION	No	No
002	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	25MG/2.5GM PACKET	No	No
003	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	50MG/5GM PACKET	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N203098-001	TESTOSTERONE	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31
N203098-002	TESTOSTERONE	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31
N203098-003	TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203098-002	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203098-003	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	2013-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203098-001	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	2013-01-31	`301d65b070ca…`

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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Testosterone	TESTOSTERONE	Amneal Pharmaceuticals NY LLC	f9888b14-67f4-4c87-8f7b-d51baef9891b	2025-07-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Upsher-Smith Laboratories, LLC	a887020f-b41f-49fe-8379-f01147b2a796	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
testosterone	TESTOSTERONE	Padagis Israel Pharmaceuticals Ltd	c0c56607-e995-4bed-9c62-e33a722b38b5	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: testosterone generic name: TESTOSTERONE
testosterone	TESTOSTERONE	Bryant Ranch Prepack	78384754-5883-46b1-84e7-c063b4b4be82	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Upsher-Smith Laboratories, LLC	10dab294-6a43-4bb3-9d91-2d200c624ffb	2025-06-10	Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Cipla USA Inc.	6a46b5de-5d95-4570-91a6-3e4278028c59	2025-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Actavis Pharma, Inc.	7227ab2f-c8ef-4bab-92ab-3092182abcc9	2025-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Zoe Processing	0bb2581c-5a65-469b-8f9a-954ac9cc90fb	2025-02-03	Warnings	Name fallback brand name: Testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Prasco Laboratories	68b2375d-0365-4797-bc3d-63531c9f42fd	2024-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
testosterone	TESTOSTERONE	Bryant Ranch Prepack	5be74193-de73-436d-a9a1-35a857bc8e0c	2024-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Prasco Laboratories	0d84e5a6-11e9-4940-8991-21c611c4c32f	2024-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE
testosterone	TESTOSTERONE	Bryant Ranch Prepack	d22a072f-529b-4878-90fc-4365d9dc67e6	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Deseret Biologicals, Inc.	c16ddade-d47a-4296-8926-d19d9f671aa3	2024-02-27	Warnings	Name fallback brand name: Testosterone generic name: TESTOSTERONE
TESTOSTERONE	TESTOSTERONE	Alembic Pharmaceuticals Inc.	21705fce-bc6c-41f6-aa92-fa6fc1c22fb6	2023-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TESTOSTERONE generic name: TESTOSTERONE
testosterone	TESTOSTERONE	Bryant Ranch Prepack	86254445-efd1-46d9-8236-3a0d98316f28	2023-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: testosterone generic name: TESTOSTERONE
Testosterone	TESTOSTERONE	Dr. Reddy's Laboratories, Inc.	ccadef00-3d5f-f926-e0fb-8dabe859f271	2019-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Testosterone generic name: TESTOSTERONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-116	Testosterone	Testosterone	Perrigo New York Inc	NDA	Current
45802-116	Testosterone	Testosterone	Perrigo New York Inc	NDA	Current
70518-1171	Testosterone	Testosterone	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45742	SUPPL	2016-11-01
45680	SUPPL	2016-10-27
24111	ORIG	2015-07-07
40260	SUPPL	2015-05-13
10159	SUPPL	2015-05-13
32371	SUPPL	2014-06-23
19421	SUPPL	2014-06-23
24427	ORIG	2013-06-28
22909	ORIG	2013-06-28
10158	ORIG	2013-02-04
19420	ORIG	2013-02-01