Application 204633

Type: ANDA
Sponsor: SIGMAPHARM LABS LLC

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	RLD / RS	Approval date
A204633-001	ACITRETIN	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22
A204633-002	ACITRETIN	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22
A204633-003	ACITRETIN	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22
A204633-004	ACITRETIN	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204633-001	AB
A204633-002	AB
A204633-003	AB
A204633-004	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`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	A204633-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204633-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204633-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-004	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACITRETIN	ACITRETIN	Bryant Ranch Prepack	1e87e415-070d-41f5-9d93-17793e8ad8a6	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204633 application number: ANDA204633
ACITRETIN	ACITRETIN	Bryant Ranch Prepack	08ce9fdd-1e84-4043-b085-91053f975b64	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204633 application number: ANDA204633
ACITRETIN	ACITRETIN	Bryant Ranch Prepack	a5be620f-d721-40c1-a062-d21c70bfcbed	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204633 application number: ANDA204633
ACITRETIN	ACITRETIN	AvKARE	6af396c2-af3e-436d-ba9a-583637495910	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204633 application number: ANDA204633 ndc (product): 42291-088 ndc (product): 42291-087 ndc (product): 42291-086
ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	a6546625-acb8-460e-b34e-f795bfb3680a	2023-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204633 application number: ANDA204633 ndc (product): 42794-080 ndc (product): 42794-081 ndc (product): 42794-083

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-086	ACITRETIN	ACITRETIN	AvKARE, Inc.	ANDA	Current
42291-086	ACITRETIN	ACITRETIN	AvKARE	ANDA	Current
42291-087	ACITRETIN	ACITRETIN	AvKARE, Inc.	ANDA	Current
42291-087	ACITRETIN	ACITRETIN	AvKARE	ANDA	Current
42291-088	ACITRETIN	ACITRETIN	AvKARE, Inc.	ANDA	Current
42291-088	ACITRETIN	ACITRETIN	AvKARE	ANDA	Current
42794-080	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current
42794-080	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current
42794-080	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current
42794-080	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current
42794-081	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current
42794-081	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current
42794-081	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current
42794-081	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current
42794-083	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current
42794-083	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current
42794-083	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current
42794-083	ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	ANDA	Current