Application 078103

Type: ANDA
Sponsor: LUPIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	10MG	No	No
002	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	20MG	No	No
003	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	40MG	No	No
004	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	80MG	No	No
005	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
A078103-001	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11
A078103-002	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11
A078103-003	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11
A078103-004	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11
A078103-005	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078103-001	AB
A078103-002	AB
A078103-003	AB
A078103-004	AB
A078103-005	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 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078103-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078103-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078103-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078103-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078103-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078103-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078103-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078103-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078103-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-005	AB	1	`b8a1b40f171c…`

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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMVASTATIN	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	25d9f841-31d8-4514-ac73-ffe138ff69c7	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	aaca7284-d2d8-42e3-b153-ddc3d2ce907c	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	76ea62f3-4efb-4649-829d-3f0c28d5dae7	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	d099d003-4c7c-4e35-ad6e-94ddf20035b7	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	3b0720d2-b240-48e4-af77-9ccda509fae7	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	30fe2447-4dd3-43e6-bac5-0f754ab77c3a	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103 ndc (product): 70518-0954
SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	3e48217f-8175-4e9b-9fd0-909be4bbba95	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103 ndc (product): 68180-481 ndc (product): 68180-482
SIMVASTATIN	SIMVASTATIN	Northwind Health Company, LLC	f835af8f-7d84-1978-e053-6294a90a22ae	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Northwind Health Company, LLC	f86de805-e4ec-4bca-e053-6294a90a1fc3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	8e686832-1caf-425c-9ca6-7eaade43b6fe	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	QPharma, Inc.	f71f71db-e0dd-6609-e053-6294a90a4450	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	09fa512b-f6c1-437d-be46-a8ddd36743b4	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	a53cfdd8-ca99-47a9-827d-1b06a0329878	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	450e722c-d55d-3e6d-e063-6394a90a5231	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
Simvastatin	SIMVASTATIN	American Health Packaging	4bec3923-6221-4b8b-9a72-872a63680de1	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
Simvastatin	SIMVASTATIN	American Health Packaging	51dd8d34-e660-49dc-a86e-07d031a18465	2025-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	06703194-b41a-2bbe-e063-6394a90ac41f	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	673dfc44-d407-f9ac-e053-2a91aa0a4702	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
Simvastatin	SIMVASTATIN	Direct_Rx	f42246de-62d2-212f-e053-2a95a90ac88a	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
Simvastatin	SIMVASTATIN	Direct_Rx	f5dd1835-6d40-40da-e053-2a95a90ad121	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 114 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68180-481	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-481	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-481	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-481	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-481	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-481	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-482	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-482	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-482	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-482	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-482	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-482	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68645-470	Simvastatin	Simvastatin	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-470	Simvastatin	Simvastatin	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-470	Simvastatin	Simvastatin	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-470	Simvastatin	Simvastatin	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-470	Simvastatin	Simvastatin	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-527	SIMVASTATIN	SIMVASTATIN	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-527	SIMVASTATIN	SIMVASTATIN	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-527	SIMVASTATIN	SIMVASTATIN	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-527	SIMVASTATIN	SIMVASTATIN	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-527	SIMVASTATIN	SIMVASTATIN	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
70518-0954	SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	ANDA	Current
70518-0954	SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	ANDA	Current
70518-1426	SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	ANDA	Current
70518-1426	SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	ANDA	Current
70518-1426	SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	ANDA	Current
70518-1426	SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	ANDA	Current
70518-1426	SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	ANDA	Current
70518-3349	SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	ANDA	Current
71205-192	SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	ANDA	Current
71205-192	SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	ANDA	Current
71205-192	SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	ANDA	Current
71205-192	SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	ANDA	Current