Application 208255

Type: NDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYMFI LO	EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	400MG;300MG;300MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N208255-001	SYMFI LO	EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	400MG;300MG;300MG	TABLET / ORAL		RLD	2018-02-05

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 2 of 2 · 44 observed 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
2022-10-28 04:53 UTC	2022-10	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL	AB	RLD, RS	2018-02-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208255-001	SYMFI LO	400MG;300MG;300MG	TABLET / ORAL		RLD	2018-02-05	`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	N208255-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208255-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208255-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208255-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208255-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208255-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208255-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208255-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208255-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208255-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208255-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208255-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208255-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208255-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208255-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208255-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208255-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208255-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208255-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208255-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208255-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208255-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208255-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208255-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208255-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208255-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208255-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208255-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208255-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208255-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208255-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208255-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208255-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208255-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208255-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
49502-425	SYMFI LO	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	Mylan Specialty L.P.	NDA	Current
49502-425	SYMFI LO	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	Mylan Specialty L.P.	NDA	Current
49502-425	SYMFI LO	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	Mylan Specialty L.P.	NDA	Current
49502-425	SYMFI LO	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	Mylan Specialty L.P.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60754	SUPPL	2019-10-31
60728	SUPPL	2019-10-30
55857	ORIG	2018-10-10
52771	ORIG	2018-02-09
52770	ORIG	2018-02-06
62973	ORIG	1900-01-01
62972	ORIG	1900-01-01