Application 202552

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACITRETIN	ACITRETIN	CAPSULE;ORAL	10MG	No	No
002	ACITRETIN	ACITRETIN	CAPSULE;ORAL	17.5MG	No	No
003	ACITRETIN	ACITRETIN	CAPSULE;ORAL	22.5MG	No	No
004	ACITRETIN	ACITRETIN	CAPSULE;ORAL	25MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202552-001	ACITRETIN	ACITRETIN	10MG	CAPSULE / ORAL	AB	2015-12-23
A202552-002	ACITRETIN	ACITRETIN	17.5MG	CAPSULE / ORAL	AB	2015-12-23
A202552-003	ACITRETIN	ACITRETIN	22.5MG	CAPSULE / ORAL	AB	2015-12-23
A202552-004	ACITRETIN	ACITRETIN	25MG	CAPSULE / ORAL	AB	2015-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A202552-001	AB
A202552-002	AB
A202552-003	AB
A202552-004	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 5 · 164 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	A202552-001	ACITRETIN	10MG	CAPSULE / ORAL	AB	2015-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202552-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB	2015-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202552-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB	2015-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202552-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	2015-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202552-001	ACITRETIN	10MG	CAPSULE / ORAL	AB	2015-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202552-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB	2015-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202552-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB	2015-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202552-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	2015-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202552-001	ACITRETIN	10MG	CAPSULE / ORAL	AB	2015-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202552-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB	2015-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202552-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB	2015-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202552-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	2015-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202552-001	ACITRETIN	10MG	CAPSULE / ORAL	AB	2015-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202552-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB	2015-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202552-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB	2015-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202552-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	2015-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202552-001	ACITRETIN	10MG	CAPSULE / ORAL	AB	2015-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202552-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB	2015-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202552-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB	2015-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202552-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	2015-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202552-001	ACITRETIN	10MG	CAPSULE / ORAL	AB	2015-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202552-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB	2015-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202552-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB	2015-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202552-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	2015-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202552-001	ACITRETIN	10MG	CAPSULE / ORAL	AB	2015-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202552-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB	2015-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202552-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB	2015-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202552-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	2015-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202552-001	ACITRETIN	10MG	CAPSULE / ORAL	AB	2015-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202552-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB	2015-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202552-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB	2015-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202552-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	2015-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202552-001	ACITRETIN	10MG	CAPSULE / ORAL	AB	2015-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202552-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB	2015-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202552-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB	2015-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202552-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	2015-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202552-001	ACITRETIN	10MG	CAPSULE / ORAL	AB	2015-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202552-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB	2015-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202552-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB	2015-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202552-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	2015-12-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A202552-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202552-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202552-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202552-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202552-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202552-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202552-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202552-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202552-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202552-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202552-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202552-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202552-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202552-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202552-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202552-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202552-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202552-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202552-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202552-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202552-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202552-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202552-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202552-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202552-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202552-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202552-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202552-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202552-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202552-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202552-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202552-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202552-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202552-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202552-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202552-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202552-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202552-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202552-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202552-004	AB	1	`d06236e962d9…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acitretin	ACITRETIN	Amneal Pharmaceuticals of New York LLC	85507f6c-f802-479e-bacc-624b5136d092	2024-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202552 application number: ANDA202552 ndc (product): 0115-1752 ndc (product): 0115-1751 ndc (product): 0115-1750 ndc (product): 0115-1753

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1667	Acitretin	Acitretin	Impax Generics	ANDA	Current
0115-1668	Acitretin	Acitretin	Impax Generics	ANDA	Current
0115-1669	Acitretin	Acitretin	Impax Generics	ANDA	Current
0115-1698	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1698	Acitretin	Acitretin	Impax Generics	ANDA	Current
0115-1698	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1750	Acitretin	Acitretin	Impax Generics	ANDA	Current
0115-1750	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1750	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1750	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1751	Acitretin	Acitretin	Impax Generics	ANDA	Current
0115-1751	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1751	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1751	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1752	Acitretin	Acitretin	Impax Generics	ANDA	Current
0115-1752	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1752	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1752	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1753	Acitretin	Acitretin	Impax Generics	ANDA	Current
0115-1753	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1753	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1753	Acitretin	Acitretin	Amneal Pharmaceuticals of New York LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32273	ORIG	2015-12-29