Application 210275

Type: ANDA
Sponsor: MYLAN

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 44.

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	Approval date
A210275-001	POMALIDOMIDE	POMALIDOMIDE	1MG	CAPSULE / ORAL	2022-01-26
A210275-002	POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE / ORAL	2022-01-26
A210275-003	POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE / ORAL	2022-01-26
A210275-004	POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE / ORAL	2022-01-26

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 2 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210275-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	2022-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210275-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	2022-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210275-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	2022-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210275-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	2022-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210275-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	2022-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210275-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	2022-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210275-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	2022-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210275-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	2022-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210275-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	2022-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210275-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	2022-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210275-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	2022-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210275-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	2022-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210275-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	2022-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210275-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	2022-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210275-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	2022-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210275-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	2022-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210275-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	2022-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210275-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	2022-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210275-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	2022-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210275-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	2022-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210275-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	2022-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210275-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	2022-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210275-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	2022-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210275-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	2022-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210275-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	2022-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210275-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	2022-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210275-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	2022-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210275-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	2022-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210275-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	2022-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210275-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	2022-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210275-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	2022-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210275-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	2022-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210275-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	2022-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210275-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	2022-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210275-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	2022-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210275-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	2022-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210275-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	2022-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210275-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	2022-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210275-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	2022-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210275-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	2022-01-26	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A210275-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210275-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210275-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210275-004	AB	1	`bb7c543d1eb4…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pomalidomide	POMALIDOMIDE	Sun Pharmaceutical Industries, Inc.	3c222961-5398-4185-b2d0-defe90230094	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Pomalidomide generic name: POMALIDOMIDE
Pomalidomide	POMALIDOMIDE	Cipla USA Inc.	a0c16478-1a0c-4be0-be75-cb9e4543d71a	2026-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Pomalidomide generic name: POMALIDOMIDE
pomalidomide	POMALIDOMIDE	Dr. Reddy's Laboratories Inc.	84678d19-fd8d-268e-2fe6-88e21195fcca	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: pomalidomide generic name: POMALIDOMIDE
Pomalidomide	POMALIDOMIDE	Sandoz Inc	4fcd4978-b2d1-4d1a-b239-717cddb8be1f	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Pomalidomide generic name: POMALIDOMIDE
Pomalidomide	POMALIDOMIDE	Apotex Corp.	b1a1c713-d23b-5ede-1ae0-0bbba47221df	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Pomalidomide generic name: POMALIDOMIDE
Pomalidomide	POMALIDOMIDE	Breckenridge Pharmaceutical, Inc.	41400b90-b64e-447b-90f3-1cad58050eba	2026-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Pomalidomide generic name: POMALIDOMIDE
Pomalidomide	POMALIDOMIDE	Camber Pharmaceuticals, Inc.	52676691-e171-467c-ae55-b5dcc14062a4	2026-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Pomalidomide generic name: POMALIDOMIDE
Pomalidomide	POMALIDOMIDE	Aurobindo Pharma Limited	1539fbf9-8281-4c7b-827b-9f53b50d9042	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Pomalidomide generic name: POMALIDOMIDE
Pomalidomide	POMALIDOMIDE	Natco Pharma Limited	0169dbda-53df-4cd9-b989-ff7544f1bdf5	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Pomalidomide generic name: POMALIDOMIDE
Pomalidomide	POMALIDOMIDE	Teva Pharmaceuticals, Inc.	dee932c5-0c7c-45f0-b2bb-c027badee537	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Pomalidomide generic name: POMALIDOMIDE
Pomalyst	POMALIDOMIDE	Celgene Corporation	2b25ef01-5c9e-11e1-b86c-0800200c9a66	2025-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: POMALIDOMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76287	ORIG	2023-11-03