Application 210111

Type: ANDA
Sponsor: BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POMALIDOMIDE	POMALIDOMIDE	CAPSULE;ORAL	1MG	No	No
002	POMALIDOMIDE	POMALIDOMIDE	CAPSULE;ORAL	2MG	No	No
003	POMALIDOMIDE	POMALIDOMIDE	CAPSULE;ORAL	3MG	No	No
004	POMALIDOMIDE	POMALIDOMIDE	CAPSULE;ORAL	4MG	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
A210111-001	POMALIDOMIDE	POMALIDOMIDE	1MG	CAPSULE / ORAL	AB	2020-10-30
A210111-002	POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE / ORAL	AB	2020-10-30
A210111-003	POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE / ORAL	AB	2020-10-30
A210111-004	POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE / ORAL	AB	2020-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210111-001	AB
A210111-002	AB
A210111-003	AB
A210111-004	AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A210111-001	PC	2026-08-29
A210111-002	PC	2026-08-29
A210111-003	PC	2026-08-29
A210111-004	PC	2026-08-29

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 4 · 144 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	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	AB	2020-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	AB	2020-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	AB	2020-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	AB	2020-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`d06236e962d9…`

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	A210111-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-004	AB	1	`011fe1cb6892…`
2021-03-12 10:30 UTC	2021-03	A210111-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210111-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210111-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210111-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210111-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210111-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210111-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210111-004	AB	1	`8869cabd3fbd…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-004	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-001	PC	2026-08-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-002	PC	2026-08-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-003	PC	2026-08-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-004	PC	2026-08-29	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pomalidomide	POMALIDOMIDE	Breckenridge Pharmaceutical, Inc.	41400b90-b64e-447b-90f3-1cad58050eba	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210111 application number: ANDA210111
Pomalidomide	POMALIDOMIDE	Natco Pharma Limited	0169dbda-53df-4cd9-b989-ff7544f1bdf5	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210111 application number: ANDA210111

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76286	ORIG	2023-11-03
65709	ORIG	2020-12-23