Application 213038

Type: ANDA
Sponsor: LAURUS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	400MG;300MG;300MG	No	No

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

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
A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL		RS	2020-05-14

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.

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
2026-02-19 14:30 UTC	2026-02	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL		RS	2020-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL	AB		2020-05-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213038-001	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL		RS	2020-05-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213038-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213038-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213038-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213038-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213038-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213038-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213038-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213038-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213038-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213038-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213038-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213038-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213038-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213038-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213038-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213038-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213038-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213038-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213038-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213038-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213038-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213038-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213038-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213038-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213038-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213038-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213038-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213038-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213038-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213038-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213038-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213038-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213038-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213038-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213038-001	AB	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	Laurus Labs Limited	98342153-b9de-4318-aac4-9f8d19590cd7	2024-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213038 application number: ANDA213038 ndc (product): 42385-929

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42385-929	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	Laurus Labs Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63454	ORIG	2020-06-08