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 4 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	A-S Medication Solutions	a2b879ae-eaf3-4a36-abd0-986add4a73ac	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	66777aaa-370a-4121-9246-c0866098f4a4	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	658cf877-f7cd-4ec8-84a3-08c27a06ccda	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Accord Healthcare, Inc.	871251c0-36a1-4a32-9eab-ff6c1e925ca9	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	American Health Packaging	4bec3923-6221-4b8b-9a72-872a63680de1	2025-08-25	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	American Health Packaging	51dd8d34-e660-49dc-a86e-07d031a18465	2025-05-20	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	6de29f85-92e9-4a28-9bcc-6789f2f698de	2025-04-25	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	9133520e-1ffd-4ef1-bced-6b0c9a579f39	2025-04-24	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Westminster Pharmaceuticals, LLC	acaaab63-c9ff-44c9-8fde-9a4ea6454dd7	2025-04-21	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
ZOCOR	SIMVASTATIN	Organon LLC	8f55d5de-5a4f-4a39-8c84-c53976dd6af9	2025-03-28	Warnings, Adverse reactions	Name fallback generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	492f6b4e-ca25-4f59-9f9d-3f465061b7b1	2025-02-12	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	cf85b795-82fa-3389-e053-2995a90af2fd	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	cf859977-2d84-0fcb-e053-2a95a90a6269	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	06703194-b41a-2bbe-e063-6394a90ac41f	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	0a1fe17b-75d4-d361-e063-6394a90ae188	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	673dfc44-d407-f9ac-e053-2a91aa0a4702	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Direct_Rx	f42246de-62d2-212f-e053-2a95a90ac88a	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Direct_Rx	f5dd1835-6d40-40da-e053-2a95a90ad121	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Direct_Rx	f7aa095f-590c-98e3-e053-6394a90ad972	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	56456210-2db5-4f0d-e054-00144ff8d46c	2024-12-26	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