Application 211083

Type: ANDA
Sponsor: ACCORD HLTHCARE INC

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 44.

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	Approval date
A211083-001	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2020-07-02
A211083-002	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2020-07-02
A211083-003	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2020-07-02

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 3 · 120 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2020-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2020-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2020-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2020-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2020-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2020-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2020-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2020-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2020-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2020-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2020-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2020-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2020-07-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2020-07-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2020-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2020-07-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2020-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2020-07-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2020-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2020-07-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2020-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2020-07-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2020-07-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2020-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2020-07-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2020-07-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211083-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2020-07-02	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211083-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2020-07-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211083-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2020-07-02	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A211083-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211083-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211083-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211083-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211083-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211083-003	AB	1	`c0c555d07b60…`

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 · 6 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	Name fallback brand name: ERLOTINIB HYDROCHLORIDE generic name: ERLOTINIB HYDROCHLORIDE
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ccf1e415-4980-462f-8ac2-87979bda149e	2023-02-17	Warnings, Adverse reactions	Name fallback brand name: ERLOTINIB HYDROCHLORIDE generic name: ERLOTINIB HYDROCHLORIDE
Erlotinib Hydrochloride	ERLOTINIB HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	4cff04f5-3693-4d87-a9f8-a2b195e3d26e	2019-12-03	Warnings, Adverse reactions	Name fallback brand name: Erlotinib Hydrochloride generic name: ERLOTINIB HYDROCHLORIDE
Erlotinib	ERLOTINIB HYDROCHLORIDE	Armas Pharmaceuticals Inc.	53cf8868-cfd8-4c6e-ad9d-3171ff1e4d8c	2019-10-25	Warnings, Adverse reactions	Name fallback generic name: ERLOTINIB HYDROCHLORIDE
Erlotinib	ERLOTINIB HYDROCHLORIDE	Armas Pharmaceuticals Inc.	2c4c7353-b81c-4651-8aac-6d15e88145af	2019-10-25	Warnings, Adverse reactions	Name fallback generic name: ERLOTINIB HYDROCHLORIDE
Erlotinib	ERLOTINIB HYDROCHLORIDE	Armas Pharmaceuticals Inc.	766baa46-1916-44e8-b599-33017a4194f1	2019-10-25	Warnings, Adverse reactions	Name fallback generic name: ERLOTINIB HYDROCHLORIDE

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
59091	ORIG	2019-06-17