Application 021543

Type: NDA
Sponsor: AUXILIUM PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STRIANT	TESTOSTERONE	TABLET, EXTENDED RELEASE;BUCCAL	30MG	Yes	No

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

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
N021543-001	STRIANT	TESTOSTERONE	30MG	TABLET, EXTENDED RELEASE / BUCCAL		RLD	2003-06-19

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD, RS	2003-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021543-001	STRIANT	30MG	TABLET, EXTENDED RELEASE / BUCCAL	RLD	2003-06-19	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021543-001	6248358	2019-08-23	U-527	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021543-001	6248358	2019-08-23	U-527	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021543-001	6248358	2019-08-23	U-527	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021543-001	6248358	2019-08-23	U-527	`ea99ee380514…`

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52244-030	Striant	testosterone	Endo Pharmaceuticals, Inc.	NDA	Current
52244-030	Striant	testosterone	Endo Pharmaceuticals, Inc.	NDA	Current
52244-030	Striant	testosterone	Endo Pharmaceuticals Inc.	NDA	Current
55056-3060	Striant	testosterone	Columbia Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45753	SUPPL	2016-11-01
45675	SUPPL	2016-10-27
37193	SUPPL	2015-05-13
28077	SUPPL	2015-05-13
28076	SUPPL	2014-06-23
15736	SUPPL	2014-06-23
37192	SUPPL	2014-03-25
5689	SUPPL	2014-03-25
28075	SUPPL	2004-11-08
15735	SUPPL	2004-11-08
42206	ORIG	2004-10-26
5688	SUPPL	2003-11-28
15734	ORIG	2003-06-22
5687	ORIG	2003-06-22