Application 091002

Type: ANDA
Sponsor: MYLAN

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
A091002-001	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11
A091002-002	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11
A091002-003	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091002-001	AB
A091002-002	AB
A091002-003	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 4 · 123 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	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091002-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091002-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2014-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091002-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-06-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A091002-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091002-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091002-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091002-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091002-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091002-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091002-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091002-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091002-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091002-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091002-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091002-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091002-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091002-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091002-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091002-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091002-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091002-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091002-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091002-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091002-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091002-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091002-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091002-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091002-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091002-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091002-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091002-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091002-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091002-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091002-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091002-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091002-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091002-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091002-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091002-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091002-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091002-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091002-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091002-001	AB	1	`8072bd15b7f6…`

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	A091002-001	PC	2019-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091002-002	PC	2019-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091002-003	PC	2019-11-05	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A091002-001	PC	2019-11-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091002-002	PC	2019-11-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091002-003	PC	2019-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091002-001	PC	2019-11-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091002-002	PC	2019-11-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091002-003	PC	2019-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091002-001	PC	2019-11-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091002-002	PC	2019-11-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091002-003	PC	2019-11-05	`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 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-7131	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7131	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7132	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7132	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7133	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7133	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
42292-051	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Institutional Inc.	ANDA	Current
42292-051	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Institutional Inc.	ANDA	Current
42292-052	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Institutional Inc.	ANDA	Current
42292-052	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Institutional Inc.	ANDA	Current
42292-053	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Institutional Inc.	ANDA	Current
42292-053	Erlotinib Hydrochloride	erlotinib hydrochloride	Mylan Institutional Inc.	ANDA	Current