Application 213065

Type: ANDA
Sponsor: ZYDUS PHARMS

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
A213065-001	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16
A213065-002	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16
A213065-003	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213065-001	AB
A213065-002	AB
A213065-003	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 · 111 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	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213065-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2020-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213065-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2020-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213065-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2020-04-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A213065-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213065-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213065-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213065-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213065-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213065-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213065-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213065-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213065-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213065-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213065-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213065-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213065-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213065-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213065-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213065-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213065-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213065-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213065-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213065-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213065-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213065-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213065-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213065-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213065-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213065-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213065-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213065-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213065-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213065-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213065-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213065-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213065-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213065-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213065-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213065-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213065-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213065-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213065-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213065-001	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	ERLOTINIB	Zydus Lifesciences Limited	daaa1329-3a3f-439c-b13d-b301daa234d4	2024-11-28		Exact identifier application applno (ANDA): 213065 application number: ANDA213065 ndc (product): 70771-1523 ndc (product): 70771-1522 ndc (product): 70771-1521
Erlotinib	ERLOTINIB	Zydus Pharmaceuticals USA Inc.	c35e019d-ec34-4e61-9400-a7ae7913e025	2023-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213065 application number: ANDA213065 ndc (product): 68382-915 ndc (product): 68382-914 ndc (product): 68382-913

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-913	Erlotinib	Erlotinib	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-913	Erlotinib	Erlotinib	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-914	Erlotinib	Erlotinib	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-914	Erlotinib	Erlotinib	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-915	Erlotinib	Erlotinib	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-915	Erlotinib	Erlotinib	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1521	Erlotinib	Erlotinib	Cadila Healthcare Limited	ANDA	Current
70771-1522	Erlotinib	Erlotinib	Cadila Healthcare Limited	ANDA	Current
70771-1523	Erlotinib	Erlotinib	Cadila Healthcare Limited	ANDA	Current