Application 020564

Type: NDA
Sponsor: VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPIVIR	LAMIVUDINE	TABLET;ORAL	150MG	Yes	No
003	EPIVIR	LAMIVUDINE	TABLET;ORAL	300MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020564-001	EPIVIR	LAMIVUDINE	150MG	TABLET / ORAL	AB	RLD	1995-11-17
N020564-003	EPIVIR	LAMIVUDINE	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020564-001	AB
N020564-003	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 · 86 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
2026-09-14 22:38:34	2026-08	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N020564-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020564-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020564-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020564-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020564-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020564-003	AB	1	`a50c72e98297…`

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 · 17 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
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

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-367	EPIVIR	lamivudine	Rebel Distributors Corp	NDA	Current
49702-203	EPIVIR	lamivudine	ViiV Healthcare Company	NDA	Current
49702-203	EPIVIR	lamivudine	ViiV Healthcare Company	NDA	Current
49702-203	EPIVIR	lamivudine	ViiV Healthcare Company	NDA	Current
49702-203	EPIVIR	lamivudine	ViiV Healthcare Company	NDA	Current
49702-204	EPIVIR	lamivudine	ViiV Healthcare Company	NDA	Current
49702-204	EPIVIR	lamivudine	ViiV Healthcare Company	NDA	Current
49702-204	EPIVIR	lamivudine	ViiV Healthcare Company	NDA	Current
49702-204	EPIVIR	lamivudine	ViiV Healthcare Company	NDA	Current
50090-0550	EPIVIR	lamivudine	A-S Medication Solutions	NDA	Current
53808-0245	EPIVIR	lamivudine	State of Florida DOH Central Pharmacy	NDA	Current
53808-0246	EPIVIR	lamivudine	State of Florida DOH Central Pharmacy	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58707	SUPPL	2019-05-15
58682	SUPPL	2019-05-14
57663	ORIG	2019-02-15
54028	SUPPL	2018-05-07
53921	SUPPL	2018-05-01
50015	SUPPL	2017-10-12
2754	SUPPL	2016-07-22
34861	SUPPL	2016-07-21
34860	SUPPL	2015-10-07
25203	SUPPL	2015-10-02
34858	SUPPL	2015-04-14
2752	SUPPL	2015-03-26
2753	SUPPL	2015-02-24
34859	SUPPL	2015-02-20
34857	SUPPL	2011-12-02
25202	SUPPL	2011-11-22
34856	SUPPL	2008-02-14
2751	SUPPL	2008-02-07
41438	SUPPL	2007-09-26
41437	SUPPL	2007-09-26
41435	SUPPL	2007-09-26
20730	SUPPL	2007-09-26
2750	SUPPL	2006-10-31
34855	SUPPL	2006-10-26
25201	SUPPL	2006-06-20
34854	SUPPL	2006-06-14
41436	SUPPL	2005-01-06
12748	SUPPL	2004-12-03
2749	SUPPL	2004-12-02
34853	SUPPL	2004-10-04
25200	SUPPL	2004-10-04
12747	SUPPL	2003-12-02
25199	SUPPL	2003-11-25
25197	SUPPL	2002-10-08
12745	SUPPL	2002-10-08
25198	SUPPL	2002-06-24
12746	SUPPL	2002-06-24
2748	SUPPL	2002-03-01
25196	SUPPL	2001-03-06
51228	SUPPL	1900-01-01
51227	SUPPL	1900-01-01
51226	SUPPL	1900-01-01