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 2 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	QPharma, Inc	f71fc0ac-223e-18c1-e053-6394a90a45ca	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Aurobindo Pharma Limited	4724dbb4-3613-4e6a-948f-a43d34f97f06	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Coupler LLC	50733b85-067d-99c3-e063-6394a90a4244	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	5c760852-800b-463e-8059-06a9a82c2225	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	7abc03f8-9d5f-4f7d-9e32-fc463ec0597c	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	807e5be4-6f87-48b4-8a3b-e4ad1061e706	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	c03ab80c-a3ae-4634-a76b-f53740db76f5	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Golden State Medical Supply, Inc.	4cc35f5f-2d3e-dedd-e063-6294a90a5cbe	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	e4d8ebf3-7f9f-4725-a104-1d1bf6e6f768	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	0ccb324f-877d-4f32-a769-7cd1637b7fad	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	00896fff-081d-4553-be8c-1999a8a73dda	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	143bf1d6-11c5-4a1f-b106-844e0435ee13	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	25d9f841-31d8-4514-ac73-ffe138ff69c7	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	aaca7284-d2d8-42e3-b153-ddc3d2ce907c	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	76ea62f3-4efb-4649-829d-3f0c28d5dae7	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	d099d003-4c7c-4e35-ad6e-94ddf20035b7	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	3b0720d2-b240-48e4-af77-9ccda509fae7	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	30fe2447-4dd3-43e6-bac5-0f754ab77c3a	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	XLCare Pharmaceuticals Inc.	433f8a86-5ad3-43db-8e62-c0812dd3d723	2026-01-19	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