Application 022309

Type: NDA
Sponsor: ABBVIE

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N022309-001	ANDROGEL	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29
N022309-002	ANDROGEL	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07
N022309-003	ANDROGEL	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022309-001	AB
N022309-002	AB2
N022309-003	AB2

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022309-001	8466136	2026-10-12		Drug product	2013-06-24
N022309-001	8466137	2026-10-12	U-1103		2013-06-24
N022309-001	8466138	2026-10-12	U-1103		2013-06-24
N022309-001	8486925	2026-10-12		Drug product	2013-07-19
N022309-001	8729057	2026-10-12		Drug product
N022309-001	8741881	2026-10-12	U-1103		2014-06-25
N022309-001	8754070	2026-10-12		Drug product	2014-07-16
N022309-001	8759329	2026-10-12		Drug product	2014-07-09
N022309-002	8466136	2026-10-12		Drug product	2013-06-24
N022309-002	8466137	2026-10-12	U-1103		2013-06-24
N022309-002	8466138	2026-10-12	U-1103		2013-06-24
N022309-002	8486925	2026-10-12		Drug product	2013-07-19
N022309-002	8729057	2026-10-12		Drug product	2014-06-13
N022309-002	8741881	2026-10-12	U-1103		2014-06-25
N022309-002	8754070	2026-10-12		Drug product	2014-07-16
N022309-002	8759329	2026-10-12		Drug product	2014-07-09
N022309-003	8466136	2026-10-12		Drug product	2013-06-24
N022309-003	8466137	2026-10-12	U-1103		2013-06-24
N022309-003	8466138	2026-10-12	U-1103		2013-06-24
N022309-003	8486925	2026-10-12		Drug product	2013-07-19
N022309-003	8729057	2026-10-12		Drug product	2014-06-13
N022309-003	8741881	2026-10-12	U-1103		2014-06-25
N022309-003	8754070	2026-10-12		Drug product	2014-07-16
N022309-003	8759329	2026-10-12		Drug product	2014-07-09

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 · 123 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	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB2	RLD	2012-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022309-002	ANDROGEL	1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022309-003	ANDROGEL	1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2012-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022309-001	ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2011-04-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022309-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022309-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022309-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022309-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022309-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022309-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022309-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022309-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022309-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022309-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022309-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022309-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022309-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022309-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022309-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022309-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022309-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022309-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022309-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022309-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022309-002	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022309-003	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022309-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022309-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022309-002	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022309-003	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022309-001	AB	1	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 28 · 1,119 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022309-001	8466136	2026-10-12		Drug product	2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8466137	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8466138	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8486925	2026-10-12		Drug product	2013-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8729057	2026-10-12		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8741881	2026-10-12	U-1103		2014-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8754070	2026-10-12		Drug product	2014-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-001	8759329	2026-10-12		Drug product	2014-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8466136	2026-10-12		Drug product	2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8466137	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8466138	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8486925	2026-10-12		Drug product	2013-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8729057	2026-10-12		Drug product	2014-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8741881	2026-10-12	U-1103		2014-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8754070	2026-10-12		Drug product	2014-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-002	8759329	2026-10-12		Drug product	2014-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8466136	2026-10-12		Drug product	2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8466137	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8466138	2026-10-12	U-1103		2013-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8486925	2026-10-12		Drug product	2013-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8729057	2026-10-12		Drug product	2014-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8741881	2026-10-12	U-1103		2014-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8754070	2026-10-12		Drug product	2014-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022309-003	8759329	2026-10-12		Drug product	2014-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8466136	2026-10-12		Drug product	2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8466137	2026-10-12	U-1103		2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8466138	2026-10-12	U-1103		2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8486925	2026-10-12		Drug product	2013-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8729057	2026-10-12		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8741881	2026-10-12	U-1103		2014-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8754070	2026-10-12		Drug product	2014-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-001	8759329	2026-10-12		Drug product	2014-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8466136	2026-10-12		Drug product	2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8466137	2026-10-12	U-1103		2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8466138	2026-10-12	U-1103		2013-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8486925	2026-10-12		Drug product	2013-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8729057	2026-10-12		Drug product	2014-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8741881	2026-10-12	U-1103		2014-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8754070	2026-10-12		Drug product	2014-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022309-002	8759329	2026-10-12		Drug product	2014-07-09	`31067a03dcf5…`

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	Prasco Laboratories	0d84e5a6-11e9-4940-8991-21c611c4c32f	2024-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022309 application number: NDA022309

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0051-8462	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8462	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8462	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8462	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8462	Androgel	Testosterone	AbbVie Inc.	NDA	Current
50090-1306	Androgel	Testosterone	A-S Medication Solutions LLC	NDA	Current
68382-362	Testosterone	Testosterone	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-362	Testosterone	Testosterone	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-362	Testosterone	Testosterone	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-362	Testosterone	Testosterone	Zydus Pharmaceuticals USA Inc	NDA	Current
68382-362	Testosterone	Testosterone	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82872	SUPPL	2025-07-15
82837	SUPPL	2025-07-14
82836	SUPPL	2025-07-14
58915	SUPPL	2019-06-03
58754	SUPPL	2019-05-16
58752	SUPPL	2019-05-16
58657	SUPPL	2019-05-13
57926	SUPPL	2019-03-07
57831	SUPPL	2019-02-28
45770	APPL	2016-11-02
45741	SUPPL	2016-11-01
45677	SUPPL	2016-10-27
38551	SUPPL	2015-05-13
29571	SUPPL	2015-05-13
17223	SUPPL	2014-11-20
7213	SUPPL	2014-11-18
38550	SUPPL	2014-06-23
7214	SUPPL	2014-06-23
21990	SUPPL	2014-01-16
29570	SUPPL	2013-05-22
17222	SUPPL	2013-05-20
29569	SUPPL	2013-03-15
38549	SUPPL	2012-09-11
29568	SUPPL	2012-09-10
44735	ORIG	2011-11-17
21989	ORIG	2011-11-17
7212	ORIG	2011-05-05
38548	ORIG	2011-04-29