Application 211978

Type: ANDA
Sponsor: SUNSHINE LAKE

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 44.

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
A211978-001	ENTECAVIR	ENTECAVIR	0.5MG	TABLET / ORAL			2020-05-20
A211978-002	ENTECAVIR	ENTECAVIR	1MG	TABLET / ORAL			2020-05-20

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 2 of 2 · 80 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
2022-03-09 01:35 UTC	2022-03	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2020-05-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211978-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2020-05-20	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211978-001	ENTECAVIR	0.5MG	TABLET / ORAL		2020-05-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211978-002	ENTECAVIR	1MG	TABLET / ORAL		2020-05-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A211978-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211978-002	AB	1	`c0c555d07b60…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ENTECAVIR	ENTECAVIR	Yaopharma Co., Ltd.	73dea2a4-a596-477f-b66d-5a80dd019837	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENTECAVIR generic name: ENTECAVIR
Entecavir	ENTECAVIR	AvKARE	5a1cbf7e-0352-aa3b-080c-222a6423ecd8	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Entecavir generic name: ENTECAVIR
ENTECAVIR	ENTECAVIR	NorthStar RxLLC	da705339-c349-444f-a058-4f0cef2864bf	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENTECAVIR generic name: ENTECAVIR
Entecavir	ENTECAVIR	Golden State Medical Supply, Inc.	20d62f1a-2e48-69dd-e063-6294a90ace31	2026-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Entecavir generic name: ENTECAVIR
Entecavir	ENTECAVIR	Epic Pharma, LLC	d69451df-e204-4a5c-a2bb-9e6d4d519302	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Entecavir generic name: ENTECAVIR
Entecavir	ENTECAVIR	EPIC PHARMA, LLC	af4f47e2-f556-40f2-a0fd-ff81e9f27429	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Entecavir generic name: ENTECAVIR
Entecavir	ENTECAVIR	Carlsbad Technology, Inc.	1a905283-0057-a7dd-e063-6394a90a1909	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Entecavir generic name: ENTECAVIR
ENTECAVIR	ENTECAVIR ANHYDROUS	Cameron Pharmaceuticals	92a5bebd-6408-463d-933c-bab8338a677e	2025-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENTECAVIR
Entecavir	ENTECAVIR	Camber Pharmaceuticals, Inc.	01ec50a1-6c6c-46f0-8c74-73542b0a59c3	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Entecavir generic name: ENTECAVIR
Entecavir	ENTECAVIR	Zydus Lifesciences Limited	0e3b2a0a-9076-4907-bbaf-eb6a65bb9481	2024-11-28		Name fallback brand name: Entecavir generic name: ENTECAVIR
ENTECAVIR	ENTECAVIR	Solco Healthcare LLC	bb1bb6dc-0120-46e2-ad1e-d9afc221fa16	2024-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENTECAVIR generic name: ENTECAVIR
Entecavir	ENTECAVIR	American Health Packaging	a0d2e00d-21f0-4449-93b7-a19fa284d51d	2024-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Entecavir generic name: ENTECAVIR
Entecavir	ENTECAVIR	Aurobindo Pharma Limited	def332bf-2906-4a6c-b85d-dfb56bb94312	2023-11-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Entecavir generic name: ENTECAVIR
Entecavir	ENTECAVIR	Zydus Pharmaceuticals USA Inc.	b4fd0e22-ad23-4f51-9b98-95182f63c2eb	2023-10-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Entecavir generic name: ENTECAVIR
Entecavir	ENTECAVIR	Amneal Pharmaceuticals LLC	007a6ad8-4d23-4543-ae48-c651cac7dd7b	2019-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Entecavir generic name: ENTECAVIR
BARACLUDE	ENTECAVIR	E.R. Squibb & Sons, L.L.C.	046e61c9-9298-4b2e-b76e-b26b81fecd20	2019-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENTECAVIR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48792-7891	ENTECAVIR	ENTECAVIR	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7892	ENTECAVIR	ENTECAVIR	Sunshine Lake Pharma Co., Ltd.	ANDA	Current