Application 213234

Type: ANDA
Sponsor: DR REDDYS LABS LTD

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 43.

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
A213234-001	POMALIDOMIDE	POMALIDOMIDE	1MG	CAPSULE / ORAL	AB	2026-08-31
A213234-002	POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE / ORAL	AB	2026-08-31
A213234-003	POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE / ORAL	AB	2026-08-31
A213234-004	POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE / ORAL	AB	2026-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213234-001	AB
A213234-002	AB
A213234-003	AB
A213234-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213234-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	AB	2026-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213234-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	AB	2026-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213234-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	AB	2026-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213234-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	AB	2026-08-31	`84e616aacf4f…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213234-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213234-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213234-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213234-004	AB	1	`84e616aacf4f…`

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
pomalidomide	POMALIDOMIDE	Dr. Reddy's Laboratories Inc.	84678d19-fd8d-268e-2fe6-88e21195fcca	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213234 application number: ANDA213234

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
69854	ORIG	2022-01-12