Application 212984

Type: ANDA
Sponsor: ENCUBE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	50MG/5GM PACKET	No	No
002	TESTOSTERONE	TESTOSTERONE	GEL, METERED;TRANSDERMAL	12.5MG/1.25GM ACTUATION	No	No
003	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	25MG/2.5GM PACKET	No	No

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	Approval date
A212984-001	TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09
A212984-002	TESTOSTERONE	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09
A212984-003	TESTOSTERONE	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	AB1	2024-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212984-001	AB1
A212984-002	AB1
A212984-003	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 2 · 57 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	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212984-003	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	AB1	2024-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212984-003	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	AB1	2024-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212984-003	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	AB1	2024-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212984-003	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	AB1	2024-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212984-003	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	AB1	2024-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212984-003	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	AB1	2024-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212984-003	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	AB1	2024-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212984-003	TESTOSTERONE	25MG/2.5GM PACKET	GEL / TRANSDERMAL	AB1	2024-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212984-002	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED / TRANSDERMAL	AB1	2024-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212984-001	TESTOSTERONE	50MG/5GM PACKET	GEL / TRANSDERMAL	AB1	2021-11-09	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 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	A212984-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212984-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212984-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212984-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212984-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212984-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212984-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212984-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212984-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212984-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212984-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212984-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212984-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212984-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212984-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212984-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212984-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212984-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212984-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212984-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212984-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212984-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212984-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212984-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212984-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212984-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212984-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212984-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212984-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212984-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212984-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212984-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212984-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212984-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212984-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212984-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212984-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212984-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212984-001	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212984-001	AB1	1	`bb7c543d1eb4…`

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
Testosterone Gel, 1%	TESTOSTERONE GEL, 1%	Bryant Ranch Prepack	353de205-d642-4f26-875b-b9ea4707a755	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212984 application number: ANDA212984
Testosterone Gel, 1%	TESTOSTERONE GEL, 1%	Encube Ethicals, Inc.	7d655d6d-01da-488c-bd4e-c7fbe0ace38c	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212984 application number: ANDA212984 ndc (product): 21922-019

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
21922-019	Testosterone Gel, 1%	Testosterone Gel, 1%	Encube Ethicals Private Limited	ANDA	Current
21922-019	Testosterone Gel, 1%	Testosterone Gel, 1%	Encube Ethicals Private Limited	ANDA	Current
21922-019	Testosterone Gel, 1%	Testosterone Gel, 1%	Encube Ethicals Private Limited	ANDA	Current
63629-9585	Testosterone Gel, 1%	Testosterone Gel, 1%	Bryant Ranch Prepack	ANDA	Current