Application 204399

Type: NDA
Sponsor: UPSHER SMITH LABS

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204399-002	VOGELXO	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2		2014-06-04
N204399-003	VOGELXO	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX		2014-06-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N204399-002	AB2
N204399-003	BX

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204399-002	8785426	2034-02-11	U-1531	Drug product	2014-07-22
N204399-002	9295675	2034-02-11	U-1531	Drug product	2016-03-30
N204399-002	9662340	2034-02-11	U-1531	Drug product	2017-06-21
N204399-003	8785426	2034-02-11	U-1531	Drug product	2014-07-22
N204399-003	9295675	2034-02-11	U-1531	Drug product	2016-03-30
N204399-003	9662340	2034-02-11	U-1531	Drug product	2017-06-21

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 · 82 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
2026-02-19 14:30 UTC	2026-02	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204399-002	VOGELXO	50MG/5GM PACKET	GEL / TRANSDERMAL	AB2	2014-06-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204399-003	VOGELXO	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	BX	2014-06-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N204399-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204399-003	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204399-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204399-003	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204399-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204399-003	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204399-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204399-003	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204399-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204399-003	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204399-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204399-003	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204399-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204399-003	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204399-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204399-003	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204399-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204399-003	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204399-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204399-003	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204399-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204399-003	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204399-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204399-003	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204399-002	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204399-003	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204399-002	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204399-003	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204399-002	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204399-003	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204399-002	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204399-003	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204399-002	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204399-003	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204399-002	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204399-003	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204399-002	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204399-003	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204399-002	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204399-003	BX	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 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	N204399-002	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204399-002	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204399-002	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204399-003	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204399-003	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204399-003	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204399-002	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204399-002	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204399-002	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204399-003	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204399-003	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204399-003	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204399-002	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204399-002	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204399-002	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204399-003	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204399-003	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204399-003	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204399-002	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204399-002	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204399-002	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204399-003	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204399-003	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204399-003	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204399-002	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204399-002	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204399-002	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204399-003	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204399-003	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204399-003	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204399-002	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204399-002	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204399-002	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204399-003	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204399-003	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204399-003	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204399-002	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204399-002	9295675	2034-02-11	U-1531	Drug product	2016-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204399-002	9662340	2034-02-11	U-1531	Drug product	2017-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204399-003	8785426	2034-02-11	U-1531	Drug product	2014-07-22	`2680178bc6a6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vogelxo	TESTOSTERONE	Upsher-Smith Laboratories, LLC	2dd150f6-cdfd-4d51-8888-12b288f26262	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204399 application number: NDA204399 ndc (product): 0245-0872 ndc (product): 0245-0871
Testosterone	TESTOSTERONE	Upsher-Smith Laboratories, LLC	a887020f-b41f-49fe-8379-f01147b2a796	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204399 application number: NDA204399 ndc (product): 0832-1121 ndc (product): 0832-1120

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0245-0871	Vogelxo	Testosterone	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0871	Vogelxo	Testosterone	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0871	Vogelxo	Testosterone	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0871	Vogelxo	Testosterone	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0872	Vogelxo	Testosterone	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0872	Vogelxo	Testosterone	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0872	Vogelxo	Testosterone	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0872	Vogelxo	Testosterone	Upsher-Smith Laboratories, LLC	NDA	Current
0832-1120	Testosterone	Testosterone	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1120	Testosterone	Testosterone	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1120	Testosterone	Testosterone	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1121	Testosterone	Testosterone	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1121	Testosterone	Testosterone	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1121	Testosterone	Testosterone	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82862	SUPPL	2025-07-15
82853	SUPPL	2025-07-14
82852	SUPPL	2025-07-14
62803	SUPPL	2020-05-01
62802	SUPPL	2020-05-01
62792	SUPPL	2020-05-01
58916	SUPPL	2019-06-03
58733	SUPPL	2019-05-15
58732	SUPPL	2019-05-15
58672	SUPPL	2019-05-14
45743	SUPPL	2016-11-01
45681	SUPPL	2016-10-27
40384	SUPPL	2015-05-13
10338	SUPPL	2015-05-13
44900	ORIG	2015-04-22
22956	ORIG	2015-04-22
24122	ORIG	2014-06-26
40383	ORIG	2014-06-10
10337	ORIG	2014-06-05
10336	ORIG	2013-08-21