Application 204869

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EFAVIRENZ	EFAVIRENZ	TABLET;ORAL	600MG	No	No

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
A204869-001	EFAVIRENZ	EFAVIRENZ	600MG	TABLET / ORAL			2018-03-12

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL		2018-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204869-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-03-12	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204869-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204869-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204869-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204869-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204869-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204869-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204869-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204869-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204869-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204869-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204869-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204869-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204869-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204869-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204869-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204869-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204869-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204869-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204869-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204869-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204869-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204869-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204869-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204869-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204869-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204869-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204869-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204869-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204869-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204869-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204869-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204869-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204869-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204869-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204869-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204869-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204869-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204869-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204869-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204869-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Efavirenz	EFAVIRENZ	Macleods Pharmaceuticals Limited	13ca3456-e5bf-4bb1-af95-b1378658a358	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Efavirenz generic name: EFAVIRENZ
Efavirenz	EFAVIRENZ	Cipla USA Inc.	92603fa5-7a2c-4bfb-9a70-aadb4fba952c	2024-03-31	Warnings, Adverse reactions	Name fallback brand name: Efavirenz generic name: EFAVIRENZ
Efavirenz	EFAVIRENZ	Aurobindo Pharma Limited	4c57ad7f-321a-46c8-851a-c895466eb8e1	2023-12-29	Warnings, Adverse reactions	Name fallback brand name: Efavirenz generic name: EFAVIRENZ
Efavirenz	EFAVIRENZ	Aurobindo Pharma Limited	c5eedb5d-4cab-4056-a14a-ffdf67701355	2023-12-29	Warnings, Adverse reactions	Name fallback brand name: Efavirenz generic name: EFAVIRENZ
Efavirenz	EFAVIRENZ	Camber Pharmaceuticals, Inc.	6d625901-fef2-4c93-9619-f8991d65413d	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Efavirenz generic name: EFAVIRENZ
EFAVIRENZ	EFAVIRENZ	XLCare Pharmaceuticals Inc.	966b815d-1d78-4b54-8f00-c5a0b67c78be	2023-01-12	Warnings, Adverse reactions	Name fallback brand name: EFAVIRENZ generic name: EFAVIRENZ

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42543-889	Efavirenz	Efavirenz	Strides Pharma Inc.	ANDA	Current
42543-889	Efavirenz	Efavirenz	Strides Pharma Inc.	ANDA	Current
51407-382	Efavirenz	Efavirenz	Golden State Medical Supply, Inc.	ANDA	Current
51407-382	Efavirenz	Efavirenz	Golden State Medical Supply, Inc.	ANDA	Current
64380-889	Efavirenz	Efavirenz	Strides Pharma Science Limited	ANDA	Current
64380-889	Efavirenz	Efavirenz	Strides Pharma Science Limited	ANDA	Current
64380-889	Efavirenz	Efavirenz	Strides Shasun Limited	ANDA	Current
64380-889	Efavirenz	Efavirenz	Strides Pharma Science Limited	ANDA	Current
64380-889	Efavirenz	Efavirenz	Strides Pharma Science Limited	ANDA	Current
70518-1100	Efavirenz	Efavirenz	REMEDYREPACK INC.	ANDA	Current
70518-1100	Efavirenz	Efavirenz	REMEDYREPACK INC.	ANDA	Current
70518-1100	Efavirenz	Efavirenz	REMEDYREPACK INC.	ANDA	Current
70518-1100	Efavirenz	Efavirenz	REMEDYREPACK INC.	ANDA	Current
70518-1100	Efavirenz	Efavirenz	REMEDYREPACK INC.	ANDA	Current