Application 021743

Type: NDA
Sponsor: OSI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TARCEVA	ERLOTINIB HYDROCHLORIDE	TABLET;ORAL	EQ 25MG BASE	Yes	No
002	TARCEVA	ERLOTINIB HYDROCHLORIDE	TABLET;ORAL	EQ 100MG BASE	Yes	No
003	TARCEVA	ERLOTINIB HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE	Yes	Yes

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	RLD / RS	Approval date
N021743-001	TARCEVA	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18
N021743-002	TARCEVA	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18
N021743-003	TARCEVA	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021743-001	TARCEVA	EQ 25MG BASE	TABLET / ORAL	RLD	2004-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021743-002	TARCEVA	EQ 100MG BASE	TABLET / ORAL	RLD	2004-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021743-003	TARCEVA	EQ 150MG BASE	TABLET / ORAL	RLD	2004-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021743-001	TARCEVA	EQ 25MG BASE	TABLET / ORAL	RLD	2004-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021743-002	TARCEVA	EQ 100MG BASE	TABLET / ORAL	RLD	2004-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021743-003	TARCEVA	EQ 150MG BASE	TABLET / ORAL	RLD	2004-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021743-001	TARCEVA	EQ 25MG BASE	TABLET / ORAL	RLD	2004-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021743-002	TARCEVA	EQ 100MG BASE	TABLET / ORAL	RLD	2004-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021743-003	TARCEVA	EQ 150MG BASE	TABLET / ORAL	RLD	2004-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021743-001	TARCEVA	EQ 25MG BASE	TABLET / ORAL	RLD	2004-11-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021743-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021743-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021743-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021743-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021743-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021743-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021743-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021743-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021743-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021743-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021743-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021743-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021743-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021743-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021743-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021743-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021743-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021743-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021743-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021743-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021743-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021743-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021743-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021743-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021743-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021743-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021743-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021743-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021743-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-003	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	N021743-001	AB	1	`053a50430f4f…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021743-001	5747498*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	RE41065*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	6900221	2020-11-09	U-875	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	6900221	2020-11-09	U-1403	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	6900221	2020-11-09	U-659	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	6900221	2020-11-09	U-1046	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	7087613	2020-11-09	U-1045		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	7087613	2020-11-09	U-659		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	7087613	2020-11-09	U-1403		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	6900221*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	7087613*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	5747498*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	RE41065*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	6900221	2020-11-09	U-659	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	6900221	2020-11-09	U-1046	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	6900221	2020-11-09	U-1403	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	6900221	2020-11-09	U-875	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	7087613	2020-11-09	U-659		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	7087613	2020-11-09	U-1403		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	7087613	2020-11-09	U-1045		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	6900221*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	7087613*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	5747498*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	RE41065*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	6900221	2020-11-09	U-875	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	6900221	2020-11-09	U-1403	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	6900221	2020-11-09	U-1046	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	6900221	2020-11-09	U-659	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	7087613	2020-11-09	U-1403		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	7087613	2020-11-09	U-1045		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	7087613	2020-11-09	U-659		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	6900221*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	7087613*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021743-001	6900221*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-001	7087613*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-002	6900221*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-002	7087613*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-003	6900221*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-003	7087613*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021743-001	6900221*PED	2021-05-09		Pediatric extension	`87673890dc5c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021743-001	D-164	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	M-181	2019-06-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	M-190	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	D-164	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	M-181	2019-06-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	M-190	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	D-164	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	M-181	2019-06-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	M-190	2019-10-18	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021743-001	D-164	2019-05-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-001	M-181	2019-06-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-001	M-190	2019-10-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-002	D-164	2019-05-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-002	M-181	2019-06-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-002	M-190	2019-10-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-003	D-164	2019-05-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-003	M-181	2019-06-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-003	M-190	2019-10-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021743-001	D-164	2019-05-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-001	M-181	2019-06-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-001	M-190	2019-10-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-002	D-164	2019-05-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-002	M-181	2019-06-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-002	M-190	2019-10-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-003	D-164	2019-05-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-003	M-181	2019-06-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-003	M-190	2019-10-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021743-001	D-164	2019-05-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-001	M-181	2019-06-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-001	M-190	2019-10-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-002	D-164	2019-05-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-002	M-181	2019-06-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-002	M-190	2019-10-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-003	D-164	2019-05-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-003	M-181	2019-06-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-003	M-190	2019-10-18	`ea99ee380514…`

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 generic name: ERLOTINIB HYDROCHLORIDE
ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ccf1e415-4980-462f-8ac2-87979bda149e	2023-02-17	Warnings, Adverse reactions	Name fallback generic name: ERLOTINIB HYDROCHLORIDE
Erlotinib Hydrochloride	ERLOTINIB HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	4cff04f5-3693-4d87-a9f8-a2b195e3d26e	2019-12-03	Warnings, Adverse reactions	Name fallback 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-062	TARCEVA	erlotinib hydrochloride	Genentech, Inc.	NDA	Current
50242-063	TARCEVA	erlotinib hydrochloride	Genentech, Inc.	NDA	Current
50242-064	TARCEVA	erlotinib hydrochloride	Genentech, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47287	SUPPL	2017-02-22
45565	SUPPL	2016-10-20
45552	SUPPL	2016-10-18
45489	SUPPL	2016-09-30
6100	SUPPL	2016-06-06
16292	SUPPL	2016-06-02
6099	SUPPL	2016-05-24
37567	SUPPL	2016-05-23
16291	SUPPL	2015-04-29
6098	SUPPL	2015-04-29
51719	SUPPL	2014-06-23
37566	SUPPL	2014-04-16
6097	SUPPL	2014-04-16
28504	SUPPL	2013-05-16
16290	SUPPL	2013-05-14
16289	SUPPL	2012-04-20
6096	SUPPL	2012-04-19
6095	SUPPL	2010-04-20
6094	SUPPL	2010-04-20
16288	SUPPL	2010-04-19
16287	SUPPL	2010-04-19
37565	SUPPL	2009-05-13
28503	SUPPL	2009-05-05
37564	SUPPL	2008-09-25
6093	SUPPL	2008-09-23
37563	SUPPL	2008-09-19
28502	SUPPL	2008-09-16
28501	SUPPL	2008-09-16
6092	SUPPL	2007-05-07
37562	SUPPL	2007-05-01
37561	SUPPL	2005-11-03
28500	SUPPL	2005-11-03
42294	ORIG	2005-03-28
28499	ORIG	2004-12-02
37560	ORIG	2004-11-18
63910	ORIG	1900-01-01
52478	SUPPL	1900-01-01
52477	SUPPL	1900-01-01
51718	SUPPL	1900-01-01