Application 204268

Type: ANDA
Sponsor: PERRIGO ISRAEL

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204268-001	TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB		2015-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204268-001	AB

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 · 42 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	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204268-001	TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED / TRANSDERMAL	AB	2015-08-04	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A204268-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204268-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204268-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204268-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204268-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204268-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204268-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204268-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204268-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204268-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204268-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204268-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204268-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204268-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204268-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204268-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204268-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204268-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204268-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204268-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204268-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204268-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204268-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204268-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204268-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204268-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204268-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204268-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204268-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204268-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204268-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204268-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204268-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204268-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204268-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204268-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204268-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204268-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204268-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204268-001	AB	1	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204268-001	PC	2019-04-10	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204268-001	PC	2019-04-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204268-001	PC	2019-04-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204268-001	PC	2019-04-10	`ea99ee380514…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
testosterone	TESTOSTERONE	Padagis Israel Pharmaceuticals Ltd	54fcdcb9-fb0e-4164-9e51-f2a5feae3217	2025-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204268 application number: ANDA204268 ndc (product): 45802-754
testosterone	TESTOSTERONE	Bryant Ranch Prepack	9e10a37a-9c40-456b-a362-2fa8eae31e84	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204268 application number: ANDA204268
testosterone	TESTOSTERONE	Bryant Ranch Prepack	78384754-5883-46b1-84e7-c063b4b4be82	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204268 application number: ANDA204268 ndc (product): 63629-8455
testosterone	TESTOSTERONE	Bryant Ranch Prepack	86254445-efd1-46d9-8236-3a0d98316f28	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204268 application number: ANDA204268

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-967	testosterone	testosterone	Northstar Rx LLC	ANDA	Current
16714-967	testosterone	testosterone	Northstar RxLLC	ANDA	Current
16714-967	testosterone	testosterone	Northstar RxLLC	ANDA	Current
16714-967	testosterone	testosterone	Northstar RxLLC	ANDA	Current
45802-754	testosterone	testosterone	Perrigo New York Inc	ANDA	Current
45802-754	testosterone	testosterone	Perrigo New York Inc	ANDA	Current
45802-754	testosterone	testosterone	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-754	testosterone	testosterone	Perrigo New York Inc	ANDA	Current
45802-754	testosterone	testosterone	Perrigo New York Inc	ANDA	Current
63629-8455	testosterone	testosterone	Bryant Ranch Prepack	ANDA	Current
63629-8455	testosterone	testosterone	Bryant Ranch Prepack	ANDA	Current
63629-8455	testosterone	testosterone	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24121	ORIG	2015-08-14
10314	ORIG	2015-08-06