Application 206745

Type: ANDA
Sponsor: ZYDUS 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
A206745-001	ENTECAVIR	ENTECAVIR	0.5MG	TABLET / ORAL	AB		2017-06-23
A206745-002	ENTECAVIR	ENTECAVIR	1MG	TABLET / ORAL	AB		2017-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206745-001	AB
A206745-002	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	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`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	A206745-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206745-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206745-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206745-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206745-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206745-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206745-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206745-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206745-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206745-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206745-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206745-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206745-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206745-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206745-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206745-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206745-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206745-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206745-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206745-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206745-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206745-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206745-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206745-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206745-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206745-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206745-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206745-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206745-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206745-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206745-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206745-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206745-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206745-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206745-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206745-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206745-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206745-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206745-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206745-002	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	Zydus Lifesciences Limited	0e3b2a0a-9076-4907-bbaf-eb6a65bb9481	2024-11-28		Exact identifier application applno (ANDA): 206745 application number: ANDA206745 ndc (product): 70771-1020 ndc (product): 70771-1019
Entecavir	ENTECAVIR	Zydus Pharmaceuticals USA Inc.	b4fd0e22-ad23-4f51-9b98-95182f63c2eb	2023-10-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206745 application number: ANDA206745 ndc (product): 68382-921 ndc (product): 68382-920

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-920	Entecavir	Entecavir	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-920	Entecavir	Entecavir	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-920	Entecavir	Entecavir	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-920	Entecavir	Entecavir	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-921	Entecavir	Entecavir	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-921	Entecavir	Entecavir	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-921	Entecavir	Entecavir	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-921	Entecavir	Entecavir	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1019	Entecavir	Entecavir	Cadila Healthcare Limited	ANDA	Current
70771-1019	Entecavir	Entecavir	Cadila Healthcare Limited	ANDA	Current
70771-1019	Entecavir	Entecavir	Zydus Lifesciences Limited	ANDA	Current
70771-1020	Entecavir	Entecavir	Cadila Healthcare Limited	ANDA	Current
70771-1020	Entecavir	Entecavir	Cadila Healthcare Limited	ANDA	Current
70771-1020	Entecavir	Entecavir	Zydus Lifesciences Limited	ANDA	Current