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 1 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMVASTATIN	SIMVASTATIN	Preferred Pharmaceuticals, Inc.	68f6c856-ea98-4872-b4df-a6e9e70444fc	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Preferred Pharmaceuticals, Inc.	3f6fad0b-0278-433f-86db-761b673a5803	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Preferred Pharmaceuticals, Inc.	e73ec981-e477-4412-befd-7b807aceb32e	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	593f0007-9690-4de5-b1e9-59299e587643	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Cardinal Health 107, LLC	b2d6c7ac-304b-4cba-974c-d9a23a069925	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	d053fee4-b797-4a82-8865-0b4d08b14990	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	58cd6c9a-3429-24eb-e063-6394a90a6984	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	e59bf31f-d880-4d9e-b6c2-5a18a53718f9	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	e447cc46-adee-4126-8b85-f00f81a6e93c	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	55f92c72-e690-85dd-e063-6394a90adb39	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	St. Mary's Medical Park Pharmacy	f94d5907-737e-df67-e053-6394a90a82a6	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	a3bfe314-1fe4-4d2a-aecb-4194f3bd8f22	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	St. Mary's Medical Park Pharmacy	faa81817-3ffa-b83c-e053-6294a90a3f85	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	St. Mary's Medical Park Pharmacy	f94e5e28-f0b1-700a-e053-6394a90adb7b	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Coupler LLC	5257271e-5c07-4996-e063-6394a90a4424	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Coupler LLC	52573b98-6e51-9753-e063-6294a90ac8c4	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	5ae78a86-ccca-4714-b77e-7bc885b674b5	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	522d0f7f-f20b-bc17-e063-6294a90a3648	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	aa8aed58-691b-472e-8e98-53d0d3f56686	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	7463b093-c2ee-49c3-a08a-e758de66422a	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23917	ORIG	2011-05-26