Home Applications 209267 Application 209267
Type ANDA
Sponsor HETERO LABS LTD V Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE No No 002 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE No No 003 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE 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 RLD / RS Approval date A209267-001 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 A209267-002 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 A209267-003 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209267-002 ERLOTINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2024-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209267-003 ERLOTINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2024-05-24 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209267-001 ERLOTINIB HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2024-05-24 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 ERLOTINIB ERLOTINIB Camber Pharmaceuticals, Inc. a3b2d622-b4d5-4819-862b-f8fd3adcec6f 2024-06-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209267 application number: ANDA209267