Application 212333

Type: ANDA
Sponsor: UPSHER SMITH LABS

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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212333-001	ISOTRETINOIN	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21
A212333-002	ISOTRETINOIN	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21
A212333-003	ISOTRETINOIN	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212333-001	AB2
A212333-002	AB2
A212333-003	AB2

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 3 · 99 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	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212333-002	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2021-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212333-003	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2021-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212333-001	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2021-09-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	A212333-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212333-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212333-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212333-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212333-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212333-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212333-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212333-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212333-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212333-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212333-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212333-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212333-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212333-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212333-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212333-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212333-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212333-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212333-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212333-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212333-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212333-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212333-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212333-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212333-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212333-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212333-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212333-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212333-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212333-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212333-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212333-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212333-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212333-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212333-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212333-003	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212333-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212333-002	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212333-003	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212333-001	AB2	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isotretinoin	ISOTRETINOIN	Upsher-Smith Laboratories, LLC	08529687-26b2-41e5-b6fb-35b4c0d891fe	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212333 application number: ANDA212333 ndc (product): 0245-0573 ndc (product): 0245-0570 ndc (product): 0245-0571
Isotretinoin	ISOTRETINOIN	Mayne Pharma	ebe1b3e3-1013-4cf6-bdc8-2baa3dc26e16	2022-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212333 application number: ANDA212333 ndc (product): 68308-570 ndc (product): 68308-573 ndc (product): 68308-571

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0245-0570	Isotretinoin	Isotretinoin	Upsher-Smith Laboratories, LLC	ANDA	Current
0245-0570	Isotretinoin	Isotretinoin	Upsher-Smith Laboratories, LLC	ANDA	Current
0245-0571	Isotretinoin	Isotretinoin	Upsher-Smith Laboratories, LLC	ANDA	Current
0245-0571	Isotretinoin	Isotretinoin	Upsher-Smith Laboratories, LLC	ANDA	Current
0245-0573	Isotretinoin	Isotretinoin	Upsher-Smith Laboratories, LLC	ANDA	Current
0245-0573	Isotretinoin	Isotretinoin	Upsher-Smith Laboratories, LLC	ANDA	Current
68308-570	Isotretinoin	Isotretinoin	Mayne Pharma	ANDA	Current
68308-570	Isotretinoin	Isotretinoin	Mayne Pharma	ANDA	Current
68308-571	Isotretinoin	Isotretinoin	Mayne Pharma	ANDA	Current
68308-571	Isotretinoin	Isotretinoin	Mayne Pharma	ANDA	Current
68308-573	Isotretinoin	Isotretinoin	Mayne Pharma	ANDA	Current
68308-573	Isotretinoin	Isotretinoin	Mayne Pharma	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76356	ORIG	2023-11-06
67423	ORIG	2021-05-06