Application 206679

Type: NDA
Sponsor: TCG FLUENT PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLOLIPID	SIMVASTATIN	SUSPENSION;ORAL	20MG/5ML	Yes	No
002	FLOLIPID	SIMVASTATIN	SUSPENSION;ORAL	40MG/5ML	Yes	Yes

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

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
N206679-001	FLOLIPID	SIMVASTATIN	20MG/5ML	SUSPENSION / ORAL		RLD	2016-04-21
N206679-002	FLOLIPID	SIMVASTATIN	40MG/5ML	SUSPENSION / ORAL		RLD, RS	2016-04-21

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N206679-001	10300041	2027-04-26	Drug product	2019-10-18
N206679-001	9597289	2030-02-23	Drug product	2017-04-21
N206679-002	10300041	2027-04-26	Drug product	2019-10-18
N206679-002	9597289	2030-02-23	Drug product	2017-04-21

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206679-001	FLOLIPID	20MG/5ML	SUSPENSION / ORAL	RLD	2016-04-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206679-002	FLOLIPID	40MG/5ML	SUSPENSION / ORAL	RLD, RS	2016-04-21	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 174 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N206679-001	10300041	2027-04-26	Drug product	2019-10-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206679-001	9597289	2030-02-23	Drug product	2017-04-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206679-002	10300041	2027-04-26	Drug product	2019-10-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206679-002	9597289	2030-02-23	Drug product	2017-04-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206679-001	10300041	2027-04-26	Drug product	2019-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206679-001	9597289	2030-02-23	Drug product	2017-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206679-002	10300041	2027-04-26	Drug product	2019-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206679-002	9597289	2030-02-23	Drug product	2017-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206679-001	10300041	2027-04-26	Drug product	2019-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206679-001	9597289	2030-02-23	Drug product	2017-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206679-002	10300041	2027-04-26	Drug product	2019-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206679-002	9597289	2030-02-23	Drug product	2017-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206679-001	10300041	2027-04-26	Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206679-001	9597289	2030-02-23	Drug product	2017-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206679-002	10300041	2027-04-26	Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206679-002	9597289	2030-02-23	Drug product	2017-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206679-001	10300041	2027-04-26	Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206679-001	9597289	2030-02-23	Drug product	2017-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206679-002	10300041	2027-04-26	Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206679-002	9597289	2030-02-23	Drug product	2017-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206679-001	10300041	2027-04-26	Drug product	2019-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206679-001	9597289	2030-02-23	Drug product	2017-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206679-002	10300041	2027-04-26	Drug product	2019-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206679-002	9597289	2030-02-23	Drug product	2017-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206679-001	10300041	2027-04-26	Drug product	2019-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206679-001	9597289	2030-02-23	Drug product	2017-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206679-002	10300041	2027-04-26	Drug product	2019-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206679-002	9597289	2030-02-23	Drug product	2017-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206679-001	10300041	2027-04-26	Drug product	2019-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206679-001	9597289	2030-02-23	Drug product	2017-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206679-002	10300041	2027-04-26	Drug product	2019-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206679-002	9597289	2030-02-23	Drug product	2017-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206679-001	10300041	2027-04-26	Drug product	2019-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206679-001	9597289	2030-02-23	Drug product	2017-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206679-002	10300041	2027-04-26	Drug product	2019-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206679-002	9597289	2030-02-23	Drug product	2017-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206679-001	10300041	2027-04-26	Drug product	2019-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206679-001	9597289	2030-02-23	Drug product	2017-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206679-002	10300041	2027-04-26	Drug product	2019-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206679-002	9597289	2030-02-23	Drug product	2017-04-21	`2680178bc6a6…`

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 6 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	c0a303c5-6277-47ce-bb8a-bd5400fd8261	2023-03-20	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	d09f88b5-b95f-4315-9b75-c09ce3d94397	2023-03-13	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Proficient Rx LP	b5b47d5b-f953-4e82-99ef-e4e10164095e	2023-03-01	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	A-S Medication Solutions	aaeebbc3-2608-41b5-8420-5a2a80316d39	2023-02-04	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	8850724a-a431-46e5-b88e-1d77b0b62d6e	2022-09-26	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Proficient Rx LP	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	2022-05-01	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	7649bec7-04c6-47b5-a050-15923006dac0	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	a753846e-4cd5-4ddc-a4f2-c45da571c883	2021-12-23	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	37860f3f-984e-419a-a262-3bacc766953e	2021-12-13	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	b5bebcd0-84e6-410d-af96-63834d262bad	2021-04-27	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	121b0e00-abb7-4e07-a7b2-311be89fabb7	2019-03-25	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29273-401	FloLipid	Simvastatin	Salerno Pharmaceuticals Co.	NDA	Current
29273-401	FloLipid	Simvastatin	Salerno Pharmaceuticals Co.	NDA	Current
29273-401	FloLipid	Simvastatin	Salerno Pharmaceuticals Co.	NDA	Current
29273-402	FloLipid	Simvastatin	Salerno Pharmaceuticals Co.	NDA	Current
29273-402	FloLipid	Simvastatin	Salerno Pharmaceuticals Co.	NDA	Current
29273-402	FloLipid	Simvastatin	Salerno Pharmaceuticals Co.	NDA	Current
73308-354	SIMVASTATIN	Simvastatin	Ayurax	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64716	SUPPL	2020-09-29
64706	SUPPL	2020-09-28
49974	SUPPL	2017-10-06
49950	SUPPL	2017-10-05
46048	ORIG	2016-10-20
46045	ORIG	2016-10-20
10591	ORIG	2016-04-28
19730	ORIG	2016-04-27