Application 207792

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOTRETINOIN	ISOTRETINOIN	CAPSULE;ORAL	10MG	No	No
002	ISOTRETINOIN	ISOTRETINOIN	CAPSULE;ORAL	20MG	No	No
003	ISOTRETINOIN	ISOTRETINOIN	CAPSULE;ORAL	30MG	No	No
004	ISOTRETINOIN	ISOTRETINOIN	CAPSULE;ORAL	40MG	No	No

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

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
A207792-001	ISOTRETINOIN	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2017-09-29
A207792-002	ISOTRETINOIN	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2017-09-29
A207792-003	ISOTRETINOIN	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2017-09-29
A207792-004	ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2017-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207792-001	AB1
A207792-002	AB1
A207792-003	AB1
A207792-004	AB1

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 · 168 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	A207792-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2017-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207792-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2017-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207792-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2017-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207792-004	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2017-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207792-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2017-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207792-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2017-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207792-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2017-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207792-004	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2017-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207792-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2017-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207792-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2017-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207792-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2017-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207792-004	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2017-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207792-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2017-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207792-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2017-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207792-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2017-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207792-004	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2017-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207792-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2017-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207792-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2017-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207792-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2017-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207792-004	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2017-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207792-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2017-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207792-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2017-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207792-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2017-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207792-004	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2017-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207792-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2017-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207792-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2017-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207792-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2017-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207792-004	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2017-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207792-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2017-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207792-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2017-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207792-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2017-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207792-004	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2017-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207792-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2017-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207792-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2017-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207792-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2017-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207792-004	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2017-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207792-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2017-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207792-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2017-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207792-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2017-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207792-004	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2017-09-29	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A207792-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207792-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207792-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207792-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207792-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207792-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207792-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207792-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207792-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207792-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207792-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207792-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207792-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207792-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207792-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207792-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207792-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207792-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207792-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207792-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207792-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207792-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207792-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207792-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207792-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207792-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207792-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207792-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207792-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207792-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207792-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207792-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207792-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207792-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207792-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207792-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207792-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207792-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207792-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207792-004	AB1	1	`d8e5a09893c0…`

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
Isotretinoin	ISOTRETINOIN	Amneal Pharmaceuticals LLC	c2917c3d-3499-48a0-ba53-120cb979195d	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207792 application number: ANDA207792 ndc (product): 69238-1176 ndc (product): 69238-1174 ndc (product): 69238-1175 ndc (product): 69238-1017

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-1017	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1017	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1017	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1017	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1017	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1017	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1017	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1174	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1174	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1174	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1174	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1174	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1174	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1174	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1175	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1175	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1175	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1175	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1175	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1175	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1175	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1176	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1176	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1176	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1176	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1176	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1176	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1176	Isotretinoin	Isotretinoin	Amneal Pharmaceuticals NY LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76352	ORIG	2023-11-06