Application 021015

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANDROGEL	TESTOSTERONE	GEL;TRANSDERMAL	25MG/2.5GM PACKET	Yes	No
002	ANDROGEL	TESTOSTERONE	GEL;TRANSDERMAL	50MG/5GM PACKET	Yes	Yes
003	ANDROGEL	TESTOSTERONE	GEL, METERED;TRANSDERMAL	12.5MG/1.25GM ACTUATION	Yes	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	RLD / RS	Approval date
N021015-001	ANDROGEL	TESTOSTERONE	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28
N021015-002	ANDROGEL	TESTOSTERONE	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28
N021015-003	ANDROGEL	TESTOSTERONE	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021015-001	AB1
N021015-002	AB1
N021015-003	AB1

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 · 126 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
2026-08-18 06:07:40	2026-07	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2003-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL	AB1	RLD	2000-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL	AB1	RLD	2003-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2003-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2003-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021015-002	ANDROGEL	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021015-003	ANDROGEL	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED / TRANSDERMAL		RLD	2003-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021015-001	ANDROGEL	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TRANSDERMAL		RLD	2000-02-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 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	N021015-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021015-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021015-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021015-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021015-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021015-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021015-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021015-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021015-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021015-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021015-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021015-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021015-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021015-003	AB1	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021015-003	AB1	1	`d8e5a09893c0…`
2019-12-13 00:20 UTC	2019-12	N021015-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021015-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-002	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-002	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021015-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021015-002	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021015-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021015-002	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021015-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021015-002	AB1	1	`c0c555d07b60…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021015-001	6503894	2020-08-30	U-490			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-001	9125816	2020-08-30	U-490		2015-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-001	9132089	2020-08-30	U-490		2015-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-001	6503894*PED	2021-03-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-001	9125816*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-001	9132089*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	6503894	2020-08-30	U-490			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	9125816	2020-08-30	U-490		2015-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	9132089	2020-08-30	U-490		2015-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	6503894*PED	2021-03-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	9125816*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-002	9132089*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	6503894	2020-08-30	U-490			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	9125816	2020-08-30	U-490		2015-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	9132089	2020-08-30	U-490		2015-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	6503894*PED	2021-03-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	9125816*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021015-003	9132089*PED	2021-03-02		Pediatric extension		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021015-001	6503894*PED	2021-03-01		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-001	9125816*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-001	9132089*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-002	6503894*PED	2021-03-01		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-002	9125816*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-002	9132089*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-003	6503894*PED	2021-03-01		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-003	9125816*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021015-003	9132089*PED	2021-03-02		Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-001	6503894*PED	2021-03-01		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-001	9125816*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-001	9132089*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-002	6503894*PED	2021-03-01		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-002	9125816*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-002	9132089*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-003	6503894*PED	2021-03-01		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-003	9125816*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021015-003	9132089*PED	2021-03-02		Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021015-001	6503894*PED	2021-03-01		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021015-001	9125816*PED	2021-03-02		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021015-001	9132089*PED	2021-03-02		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021015-002	6503894*PED	2021-03-01		Pediatric extension		`5aa47cf7b7d7…`

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	68b2375d-0365-4797-bc3d-63531c9f42fd	2024-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021015 application number: NDA021015

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
0051-8425	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8425	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8425	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8425	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8425	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8450	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8450	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8450	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8450	Androgel	Testosterone	AbbVie Inc.	NDA	Current
0051-8450	Androgel	Testosterone	AbbVie Inc.	NDA	Current
21695-112	Androgel	testosterone	Rebel Distributors Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82868	SUPPL	2025-07-15
82835	SUPPL	2025-07-14
82834	SUPPL	2025-07-14
58912	SUPPL	2019-06-03
58756	SUPPL	2019-05-16
58755	SUPPL	2019-05-16
58680	SUPPL	2019-05-14
57942	SUPPL	2019-03-08
57829	SUPPL	2019-02-28
45740	SUPPL	2016-11-01
45672	SUPPL	2016-10-27
26498	SUPPL	2015-05-13
14174	SUPPL	2015-05-13
35896	SUPPL	2014-12-18
26497	SUPPL	2014-11-14
14173	SUPPL	2014-06-23
4055	SUPPL	2014-06-23
26496	SUPPL	2013-05-22
14172	SUPPL	2013-05-20
26495	SUPPL	2012-09-24
14171	SUPPL	2012-09-24
26494	SUPPL	2011-12-05
35895	SUPPL	2011-12-02
23987	ORIG	2011-04-04
4054	SUPPL	2011-03-14
14170	SUPPL	2011-03-11
4053	SUPPL	2009-10-26
14169	SUPPL	2009-10-01
26493	SUPPL	2008-01-09
4052	SUPPL	2008-01-09
4051	SUPPL	2008-01-09
35894	SUPPL	2008-01-08
14168	SUPPL	2008-01-08
35893	SUPPL	2007-12-14
21355	SUPPL	2006-06-01
21354	SUPPL	2006-06-01
35892	SUPPL	2005-08-19
4050	SUPPL	2005-08-19
4048	SUPPL	2005-08-16
14167	SUPPL	2004-12-03
4049	SUPPL	2004-12-02
21353	ORIG	2004-01-15
26492	SUPPL	2003-09-30
26491	SUPPL	2003-09-29
35891	SUPPL	2002-10-22
4047	SUPPL	2002-10-22
14166	ORIG	2000-02-28
4046	ORIG	2000-02-28
53130	ORIG	1900-01-01
53129	ORIG	1900-01-01
53128	ORIG	1900-01-01
53127	ORIG	1900-01-01
53126	ORIG	1900-01-01
53125	ORIG	1900-01-01