Application 215402

Type: ANDA
Sponsor: CARNEGIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETRAVIRINE	ETRAVIRINE	TABLET;ORAL	100MG	No	No
002	ETRAVIRINE	ETRAVIRINE	TABLET;ORAL	200MG	No	No

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

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
A215402-001	ETRAVIRINE	ETRAVIRINE	100MG	TABLET / ORAL	AB		2022-04-13
A215402-002	ETRAVIRINE	ETRAVIRINE	200MG	TABLET / ORAL	AB		2022-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215402-001	AB
A215402-002	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 2 · 58 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
2026-02-19 14:30 UTC	2026-02	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215402-001	ETRAVIRINE	100MG	TABLET / ORAL	AB	2022-04-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215402-002	ETRAVIRINE	200MG	TABLET / ORAL	AB	2022-04-13	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A215402-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215402-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215402-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215402-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215402-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215402-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215402-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215402-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215402-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215402-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215402-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215402-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215402-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215402-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215402-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215402-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215402-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215402-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215402-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215402-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215402-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215402-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215402-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215402-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215402-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215402-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215402-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215402-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215402-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215402-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215402-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215402-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215402-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215402-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215402-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215402-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215402-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215402-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215402-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215402-002	AB	1	`9b2671bbb829…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ETRAVIRINE	ETRAVIRINE	Carnegie Pharmaceuticals LLC	154b621d-9a72-489f-9127-55f9bf1797a0	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215402 application number: ANDA215402 ndc (product): 80005-112 ndc (product): 80005-113
ETRAVIRINE	ETRAVIRINE	Leading Pharma, LLC	48ffeac8-38e8-4007-903a-dbffce25d679	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215402 application number: ANDA215402 ndc (product): 69315-285 ndc (product): 69315-286

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69315-285	ETRAVIRINE	ETRAVIRINE	Leading Pharma, LLC	ANDA	Current
69315-286	ETRAVIRINE	ETRAVIRINE	Leading Pharma, LLC	ANDA	Current
80005-112	ETRAVIRINE	ETRAVIRINE	Carnegie Pharmaceuticals LLC	ANDA	Current
80005-113	ETRAVIRINE	ETRAVIRINE	Carnegie Pharmaceuticals LLC	ANDA	Current