Application 204255

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTOSTERONE	TESTOSTERONE	SOLUTION, METERED;TRANSDERMAL	30MG/1.5ML ACTUATION	No	Yes

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
A204255-001	TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204255-001	AT

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204255-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	RS	2017-02-28	`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	A204255-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204255-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204255-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204255-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204255-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204255-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204255-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204255-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204255-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204255-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204255-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204255-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204255-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204255-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204255-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204255-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204255-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204255-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204255-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204255-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204255-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204255-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204255-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204255-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204255-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204255-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204255-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204255-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204255-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204255-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204255-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204255-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204255-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204255-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204255-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204255-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204255-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204255-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204255-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204255-001	AT	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
testosterone	TESTOSTERONE	Padagis Israel Pharmaceuticals Ltd	c0c56607-e995-4bed-9c62-e33a722b38b5	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204255 application number: ANDA204255 ndc (product): 45802-610
testosterone	TESTOSTERONE	Bryant Ranch Prepack	5be74193-de73-436d-a9a1-35a857bc8e0c	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204255 application number: ANDA204255
testosterone	TESTOSTERONE	Bryant Ranch Prepack	d22a072f-529b-4878-90fc-4365d9dc67e6	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204255 application number: ANDA204255 ndc (product): 63629-9310

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-610	testosterone	testosterone	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-610	testosterone	testosterone	Perrigo New York Inc	ANDA	Current
45802-610	testosterone	testosterone	Perrigo New York Inc	ANDA	Current
45802-610	testosterone	testosterone	Perrigo New York Inc	ANDA	Current
63629-9310	testosterone	testosterone	Bryant Ranch Prepack	ANDA	Current
63629-9310	testosterone	testosterone	Bryant Ranch Prepack	ANDA	Current
63629-9310	testosterone	testosterone	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47484	ORIG	2017-03-08
47445	ORIG	2017-03-03