Application 078735

Type: ANDA
Sponsor: OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	5MG	No	No
002	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	10MG	No	No
003	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	20MG	No	No
004	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	40MG	No	No
005	SIMVASTATIN	SIMVASTATIN	TABLET;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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078735-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2010-08-30
A078735-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2010-08-30
A078735-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2010-08-30
A078735-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2010-08-30
A078735-005	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2010-08-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A078735-001	AB
A078735-002	AB
A078735-003	AB
A078735-004	AB
A078735-005	AB

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078735-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2010-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078735-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2010-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078735-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2010-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078735-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2010-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078735-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2010-08-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078735-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2010-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078735-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2010-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078735-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2010-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078735-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2010-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078735-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2010-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078735-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2010-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078735-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2010-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078735-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2010-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078735-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2010-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078735-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2010-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078735-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2010-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078735-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2010-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078735-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2010-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078735-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2010-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078735-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2010-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078735-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2010-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078735-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2010-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078735-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2010-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078735-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2010-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078735-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2010-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078735-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2010-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078735-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2010-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078735-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2010-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078735-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2010-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078735-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2010-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078735-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2010-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078735-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2010-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078735-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2010-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078735-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2010-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078735-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2010-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078735-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2010-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078735-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2010-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078735-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2010-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078735-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2010-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078735-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2010-08-30	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078735-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078735-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078735-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078735-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078735-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078735-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078735-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078735-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078735-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078735-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078735-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078735-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078735-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078735-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078735-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078735-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078735-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078735-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078735-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078735-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078735-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078735-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078735-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078735-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078735-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078735-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078735-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078735-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078735-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078735-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078735-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078735-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078735-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078735-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078735-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078735-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078735-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078735-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078735-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078735-005	AB	1	`03ed91905a0d…`

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 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	1ddc0230-24ab-4e69-9c6c-6776c354c82c	2024-09-13	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	356ed6a6-e467-4791-87ff-2ae7779fc1b0	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	ce3ac5e8-bdef-d195-e0a0-e1a982008efe	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	79ca09cd-2396-4e50-b159-1f9567115067	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Quallent Pharmaceuticals Health LLC	2b4255a7-f9f5-4235-8dbb-b0f03acbd624	2024-07-23	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	54c236ce-69c2-06ef-e054-00144ff88e88	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	54c28733-eb99-10f6-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	8ed46bb1-9f84-4418-e053-2a95a90abd4b	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	8e986df7-3020-6755-e053-2995a90aca37	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	4277e75a-7f3b-4f35-ae56-0bbe095586a5	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	440dff4b-c377-48f3-bf24-07fd986b6fee	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	NorthStar Rx LLC	0376351b-f1a0-43e5-a0b4-533072c49f39	2024-04-15	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Camber Pharmaceuticals, Inc.	751b79c6-bba8-4d29-b69c-a2ac6453fec8	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	2e579278-c105-4cda-92ca-a3496d846c82	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	7fc4df06-48cb-481a-b7b2-d951def683ea	2023-12-25	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	14bd8444-1556-4636-9e56-28da21a852fc	2023-10-30	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Biocon Pharma Inc,	7b325108-6940-50a7-96b4-822a5206e568	2023-09-26	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	34c8c080-97b5-4580-b8fb-3fd557cdb40a	2023-05-03	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	dad0dd7d-3049-4be4-aaeb-8a1895d55208	2023-05-01	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
23917	ORIG	2011-05-26