Application 213267

Type
ANDA
Sponsor
NATCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THALIDOMIDETHALIDOMIDECAPSULE;ORAL150MGNoNo
002THALIDOMIDETHALIDOMIDECAPSULE;ORAL50MGNoNo
003THALIDOMIDETHALIDOMIDECAPSULE;ORAL100MGNoNo
004THALIDOMIDETHALIDOMIDECAPSULE;ORAL200MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213267-001THALIDOMIDETHALIDOMIDE150MGCAPSULE / ORAL2023-04-27
A213267-002THALIDOMIDETHALIDOMIDE50MGCAPSULE / ORALAB2026-04-24
A213267-003THALIDOMIDETHALIDOMIDE100MGCAPSULE / ORALAB2026-04-24
A213267-004THALIDOMIDETHALIDOMIDE200MGCAPSULE / ORALAB2026-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213267-002AB
A213267-003AB
A213267-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213267-001THALIDOMIDE150MGCAPSULE / ORAL2023-04-27a50c72e98297…
2026-08-01 22:54:322026-06A213267-002THALIDOMIDE50MGCAPSULE / ORALAB2026-04-24a50c72e98297…
2026-08-01 22:54:322026-06A213267-003THALIDOMIDE100MGCAPSULE / ORALAB2026-04-24a50c72e98297…
2026-08-01 22:54:322026-06A213267-004THALIDOMIDE200MGCAPSULE / ORALAB2026-04-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213267-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A213267-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A213267-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ThalomidTHALIDOMIDECelgene Corporation2eda833b-1357-4ed4-a093-194524fcb0612023-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: THALIDOMIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76278ORIG 2023-11-03
74118ORIG 2023-05-02