Application 206652

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENTECAVIR	ENTECAVIR	TABLET;ORAL	0.5MG	No	No
002	ENTECAVIR	ENTECAVIR	TABLET;ORAL	1MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206652-001	ENTECAVIR	ENTECAVIR	0.5MG	TABLET / ORAL	AB		2015-11-12
A206652-002	ENTECAVIR	ENTECAVIR	1MG	TABLET / ORAL	AB		2015-11-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A206652-001	AB
A206652-002	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 · 82 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	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A206652-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206652-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206652-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206652-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206652-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206652-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206652-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206652-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206652-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206652-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206652-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206652-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206652-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206652-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206652-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206652-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206652-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206652-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206652-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206652-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206652-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206652-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206652-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206652-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206652-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206652-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206652-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206652-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206652-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206652-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206652-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206652-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206652-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206652-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206652-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206652-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206652-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206652-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206652-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206652-002	AB	1	`782e0a99824c…`

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
Entecavir	ENTECAVIR	AvKARE	5a1cbf7e-0352-aa3b-080c-222a6423ecd8	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206652 application number: ANDA206652 ndc (product): 42291-262 ndc (product): 42291-261
Entecavir	ENTECAVIR	Amneal Pharmaceuticals LLC	007a6ad8-4d23-4543-ae48-c651cac7dd7b	2019-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206652 application number: ANDA206652 ndc (product): 65162-446 ndc (product): 65162-449

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-615	Entecavir	Entecavir	Marlex Pharmaceuticals Inc	ANDA	Current
10135-616	Entecavir	Entecavir	Marlex Pharmaceuticals Inc	ANDA	Current
42291-261	Entecavir	Entecavir	AvKARE, Inc.	ANDA	Current
42291-261	Entecavir	Entecavir	AvKARE	ANDA	Current
42291-261	Entecavir	Entecavir	AvKARE	ANDA	Current
42291-261	Entecavir	Entecavir	AvKARE	ANDA	Current
42291-261	Entecavir	Entecavir	AvKARE	ANDA	Current
42291-262	Entecavir	Entecavir	AvKARE, Inc.	ANDA	Current
42291-262	Entecavir	Entecavir	AvKARE	ANDA	Current
42291-262	Entecavir	Entecavir	AvKARE	ANDA	Current
42291-262	Entecavir	Entecavir	AvKARE	ANDA	Current
42291-262	Entecavir	Entecavir	AvKARE	ANDA	Current
65162-446	Entecavir	Entecavir	Amneal Pharmaceuticals LLC	ANDA	Current
65162-446	Entecavir	Entecavir	Amneal Pharmaceuticals LLC	ANDA	Current
65162-446	Entecavir	Entecavir	Amneal Pharmaceuticals LLC	ANDA	Current
65162-446	Entecavir	Entecavir	Amneal Pharmaceuticals LLC	ANDA	Current
65162-449	Entecavir	Entecavir	Amneal Pharmaceuticals LLC	ANDA	Current
65162-449	Entecavir	Entecavir	Amneal Pharmaceuticals LLC	ANDA	Current
65162-449	Entecavir	Entecavir	Amneal Pharmaceuticals LLC	ANDA	Current
65162-449	Entecavir	Entecavir	Amneal Pharmaceuticals LLC	ANDA	Current