Application 078064

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EFAVIRENZ	EFAVIRENZ	CAPSULE;ORAL	50MG	No	No
002	EFAVIRENZ	EFAVIRENZ	CAPSULE;ORAL	100MG	No	No
003	EFAVIRENZ	EFAVIRENZ	CAPSULE;ORAL	200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A078064-001	EFAVIRENZ	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15
A078064-002	EFAVIRENZ	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15
A078064-003	EFAVIRENZ	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15

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 4 · 126 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	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078064-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078064-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078064-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078064-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078064-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078064-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078064-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078064-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078064-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078064-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078064-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078064-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078064-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078064-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078064-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078064-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078064-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078064-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078064-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078064-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078064-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078064-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078064-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078064-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078064-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078064-003	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A078064-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078064-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078064-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078064-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078064-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078064-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078064-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078064-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078064-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078064-003	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	EFAVIRENZ	Aurobindo Pharma Limited	4c57ad7f-321a-46c8-851a-c895466eb8e1	2023-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078064 application number: ANDA078064 ndc (product): 65862-106 ndc (product): 65862-104 ndc (product): 65862-105

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64980-406	Efavirenz	Efavirenz	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-406	Efavirenz	Efavirenz	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-406	Efavirenz	Efavirenz	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-406	Efavirenz	Efavirenz	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-406	Efavirenz	Efavirenz	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-407	Efavirenz	Efavirenz	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-407	Efavirenz	Efavirenz	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-407	Efavirenz	Efavirenz	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-407	Efavirenz	Efavirenz	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-407	Efavirenz	Efavirenz	Rising Pharmaceuticals, Inc.	ANDA	Current
65862-104	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-104	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-104	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-104	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-104	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-105	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-105	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-105	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-105	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-105	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-106	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-106	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-106	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-106	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current
65862-106	Efavirenz	Efavirenz	Aurobindo Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9112	ORIG	2006-12-28