Application 204570

Type: ANDA
Sponsor: ACTAVIS LABS UT INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTOSTERONE	TESTOSTERONE	GEL, METERED;TRANSDERMAL	1.62% (20.25MG/1.25GM ACTUATION)	No	No
002	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	1.62% (20.25MG/1.25GM PACKET)	No	No
003	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	1.62% (40.5MG/2.5GM 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204570-001	TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10
A204570-002	TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17
A204570-003	TESTOSTERONE	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204570-001	AB
A204570-002	AB2
A204570-003	AB2

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 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-002	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-003	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL / TRANSDERMAL	AB2	2020-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204570-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2019-04-10	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204570-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204570-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204570-003	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204570-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204570-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204570-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204570-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204570-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204570-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204570-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204570-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204570-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204570-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204570-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204570-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204570-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204570-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204570-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204570-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204570-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204570-003	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204570-001	AB	1	`1e350fbaab3a…`

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
Testosterone	TESTOSTERONE	Actavis Pharma, Inc.	4f3c2c0a-7dab-4b50-9cae-869c3c2a8498	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204570 application number: ANDA204570 ndc (product): 0591-2924 ndc (product): 0591-2925 ndc (product): 0591-2926

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
0591-2924	Testosterone	Testosterone	Actavis Pharma, Inc.	ANDA	Current
0591-2924	Testosterone	Testosterone	Actavis Pharma, Inc.	ANDA	Current
0591-2924	Testosterone	Testosterone	Actavis Pharma, Inc.	ANDA	Current
0591-2924	Testosterone	Testosterone	Actavis Pharma, Inc.	ANDA	Current
0591-2924	Testosterone	Testosterone	Actavis Pharma, Inc.	ANDA	Current
0591-2925	Testosterone	Testosterone	Actavis Pharma, Inc.	ANDA	Current
0591-2926	Testosterone	Testosterone	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57745	ORIG	2019-02-21
55946	ORIG	2018-10-15
55490	ORIG	2018-09-14
54164	ORIG	2018-05-11
49693	ORIG	2017-09-07