Application 212464

Type: ANDA
Sponsor: PERRIGO UK FINCO LTD PARTNERSHIP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE; BENZOYL PEROXIDE	GEL; TOPICAL	0.3%;2.5%	No	No

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

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
A212464-001	ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE; BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB		2022-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212464-001	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.

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	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212464-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-05-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212464-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212464-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212464-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212464-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212464-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212464-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212464-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212464-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212464-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212464-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212464-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212464-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212464-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212464-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212464-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212464-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212464-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212464-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212464-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212464-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212464-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212464-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212464-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212464-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212464-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212464-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212464-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212464-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212464-001	AB	1	`a50c72e98297…`

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
ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE AND BENZOYL PEROXIDE	Bryant Ranch Prepack	ceae42d9-0264-4a52-a17a-af68b2538ff9	2024-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212464 application number: ANDA212464
ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE AND BENZOYL PEROXIDE	Bryant Ranch Prepack	91161d2f-8990-4268-bd74-f60cf33aa2a1	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212464 application number: ANDA212464 ndc (product): 63629-9322
ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE AND BENZOYL PEROXIDE	Padagis Israel Pharmaceuticals Ltd	92dcba02-f42f-482d-8cd5-2b5ab8fa540a	2022-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212464 application number: ANDA212464 ndc (product): 45802-853

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-853	ADAPALENE AND BENZOYL PEROXIDE	adapalene and benzoyl peroxide	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
63629-9322	ADAPALENE AND BENZOYL PEROXIDE	adapalene and benzoyl peroxide	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61151	ORIG	2019-12-04