Application 021004

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPIVIR-HBV	LAMIVUDINE	SOLUTION;ORAL	5MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021004-001	EPIVIR-HBV	LAMIVUDINE	5MG/ML	SOLUTION / ORAL		RLD	1998-12-08

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD	1998-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021004-001	EPIVIR-HBV	5MG/ML	SOLUTION / ORAL	RLD, RS	1998-12-08	`e64feba35796…`

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamivudine	LAMIVUDINE	Camber Pharmaceuticals, Inc.	6bd6b9da-df69-46db-813e-4e7f3bdecf95	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
LAMIVUDINE	LAMIVUDINE	Major Pharmaceuticals	6fd4d6b9-65ea-4988-8d6f-dd220ec5052d	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Strides Pharma Science Limited	ac824c7e-9c9f-487b-ad2f-d50eaef5cbda	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
LAMIVUDINE	LAMIVUDINE	Golden State Medical Supply, Inc.	f3637209-303e-4232-ae79-07315a990973	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
LAMIVUDINE	LAMIVUDINE	Apotex Corp.	34c02bcc-d6ff-99d4-8e6a-4a91908adca8	2025-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Golden State Medical Supply, Inc.	3c30216d-f9f5-104b-e063-6294a90af8fd	2025-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Apotex Corp.	87095352-c088-74b1-7be0-d3e293a90611	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Coupler LLC	2d7db3b2-9b3c-3031-e063-6294a90a342c	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
lamivudine	LAMIVUDINE	Camber Pharmaceuticals, Inc.	e90671c6-7fff-48f4-8898-29f02d049c8b	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Camber Pharmaceuticals, Inc.	49d53e74-3798-4463-b817-1c8beb755034	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	American Health Packaging	7ad3a998-8e4d-43a0-8930-8f7a6ae539b4	2024-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
EPIVIR	LAMIVUDINE	ViiV Healthcare Company	89226149-47fa-4f7d-bb1f-1aa7034486b8	2024-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Aurobindo Pharma Limited	a8a492ab-396a-4b7c-99b3-bcb6d3386f71	2024-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Rising Pharma Holdings, Inc.	bed2e227-8d36-40ea-bbbf-d8793bfda425	2024-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Aurobindo Pharma Limited	ba7ee31e-e8d4-4e17-b27a-d2ce69e3bb00	2024-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Lupin Pharmaceuticals, Inc.	ff3b5265-f533-4332-a861-d8c9c1664ffd	2024-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Macleods Pharmaceuticals Limited	1be30bcc-2d9f-4afc-8f09-adc840b3f2d9	2022-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE
Lamivudine	LAMIVUDINE	Ingenus Pharmaceuticals, LLC	47f8be59-178c-4bad-96a4-a5c82784f308	2018-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMIVUDINE

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
0173-0663	EPIVIR	lamivudine	GlaxoSmithKline LLC	NDA	Current
0173-0663	EPIVIR	lamivudine	GlaxoSmithKline LLC	NDA	Current
0173-0663	EPIVIR	lamivudine	GlaxoSmithKline LLC	NDA	Current
0173-0663	EPIVIR	lamivudine	GlaxoSmithKline LLC	NDA	Current
0173-0663	EPIVIR	lamivudine	GlaxoSmithKline LLC	NDA	Current
0173-0663	EPIVIR	lamivudine	GlaxoSmithKline LLC	NDA	Current
0173-0663	EPIVIR	lamivudine	GlaxoSmithKline LLC	NDA	Current
0173-0663	EPIVIR	lamivudine	GlaxoSmithKline LLC	NDA	Current
0173-0663	EPIVIR	lamivudine	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69777	SUPPL	2021-12-27
69758	SUPPL	2021-12-27
56686	SUPPL	2018-12-07
56548	SUPPL	2018-11-23
49887	SUPPL	2017-09-29
49871	SUPPL	2017-09-28
48342	SUPPL	2017-05-10
48329	SUPPL	2017-05-09
26457	SUPPL	2013-12-24
35861	SUPPL	2013-12-23
26456	SUPPL	2011-01-27
14144	SUPPL	2011-01-24
35860	SUPPL	2007-10-04
4015	SUPPL	2007-10-04
14143	SUPPL	2004-12-03
4013	SUPPL	2004-12-02
35859	SUPPL	2004-09-29
4014	SUPPL	2004-09-29
35858	SUPPL	2003-12-01
26455	SUPPL	2003-11-25
35857	SUPPL	2001-08-16
21348	SUPPL	2001-08-16
4012	SUPPL	2001-08-16
41870	ORIG	1998-12-08
35856	ORIG	1998-12-08
4011	ORIG	1998-12-08