Application 214719

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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	Approval date
A214719-001	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08
A214719-002	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08
A214719-003	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214719-001	AB
A214719-002	AB
A214719-003	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.

Product history page 1 of 3 · 99 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	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214719-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2021-07-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214719-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2021-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214719-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2021-07-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214719-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214719-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214719-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214719-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214719-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214719-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214719-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214719-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214719-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214719-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214719-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214719-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214719-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214719-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214719-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214719-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214719-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214719-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214719-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214719-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214719-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214719-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214719-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214719-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214719-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214719-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214719-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214719-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214719-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214719-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214719-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214719-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214719-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214719-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214719-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214719-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214719-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214719-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214719-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214719-001	AB	1	`8072bd15b7f6…`

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
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214719 application number: ANDA214719 ndc (product): 46708-566 ndc (product): 46708-565 ndc (product): 46708-567
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ccf1e415-4980-462f-8ac2-87979bda149e	2023-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214719 application number: ANDA214719 ndc (product): 62332-565 ndc (product): 62332-566 ndc (product): 62332-567

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-565	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-566	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-567	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
62332-565	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-566	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-567	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current