Application 021961

Type: NDA
Sponsor: SYNTHON PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIMVASTATIN	SIMVASTATIN	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	No
002	SIMVASTATIN	SIMVASTATIN	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	No	No
003	SIMVASTATIN	SIMVASTATIN	TABLET, ORALLY DISINTEGRATING;ORAL	40MG	No	No
004	SIMVASTATIN	SIMVASTATIN	TABLET, ORALLY DISINTEGRATING;ORAL	80MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021961-001	SIMVASTATIN	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09
N021961-002	SIMVASTATIN	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09
N021961-003	SIMVASTATIN	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09
N021961-004	SIMVASTATIN	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021961-001	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021961-002	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021961-003	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021961-004	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021961-001	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021961-002	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021961-003	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021961-004	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021961-001	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021961-002	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021961-003	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021961-004	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021961-001	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021961-002	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021961-003	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021961-004	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021961-001	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021961-002	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021961-003	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021961-004	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021961-001	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021961-002	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021961-003	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021961-004	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021961-001	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021961-002	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021961-003	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021961-004	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021961-001	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021961-002	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021961-003	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021961-004	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021961-001	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021961-002	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021961-003	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021961-004	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021961-001	SIMVASTATIN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021961-002	SIMVASTATIN	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021961-003	SIMVASTATIN	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021961-004	SIMVASTATIN	80MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-10-09	`5bbf6a4d5a75…`

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 brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	d09f88b5-b95f-4315-9b75-c09ce3d94397	2023-03-13	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Proficient Rx LP	b5b47d5b-f953-4e82-99ef-e4e10164095e	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	A-S Medication Solutions	aaeebbc3-2608-41b5-8420-5a2a80316d39	2023-02-04	Warnings, Adverse reactions	Name fallback brand name: simvastatin 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 brand name: SIMVASTATIN generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Proficient Rx LP	ca760e79-5d8c-4b36-9899-0d37e8e1f24e	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	7649bec7-04c6-47b5-a050-15923006dac0	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	a753846e-4cd5-4ddc-a4f2-c45da571c883	2021-12-23	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	37860f3f-984e-419a-a262-3bacc766953e	2021-12-13	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	b5bebcd0-84e6-410d-af96-63834d262bad	2021-04-27	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	121b0e00-abb7-4e07-a7b2-311be89fabb7	2019-03-25	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44162	ORIG	2011-05-26
42360	ORIG	2009-02-02
37958	ORIG	2007-10-10
28928	ORIG	2007-10-10