Application 079188

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EMTRICITABINE	EMTRICITABINE	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079188-001	EMTRICITABINE	EMTRICITABINE	200MG	CAPSULE / ORAL	AB		2023-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079188-001	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.

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	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A079188-001	EMTRICITABINE	200MG	CAPSULE / ORAL	AB	2023-03-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A079188-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079188-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079188-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079188-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079188-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079188-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079188-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079188-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079188-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079188-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079188-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079188-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079188-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079188-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079188-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079188-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079188-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079188-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079188-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079188-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079188-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079188-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079188-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A079188-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Emtricitabine	EMTRICITABINE	Aurobindo Pharma Limited	cdfb7868-3eba-46e1-a286-ca40760fd98d	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079188 application number: ANDA079188

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54170	ORIG	2018-05-11
31425	ORIG	2008-12-19