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 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	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 · 215 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
2026-09-14 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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`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	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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-005	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 3 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	Direct_Rx	f7aa095f-590c-98e3-e053-6394a90ad972	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	1ddc0230-24ab-4e69-9c6c-6776c354c82c	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103 ndc (product): 0615-7993 ndc (product): 0615-7992
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	dad0dd7d-3049-4be4-aaeb-8a1895d55208	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	8850724a-a431-46e5-b88e-1d77b0b62d6e	2022-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103 ndc (product): 0615-8056
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	7649bec7-04c6-47b5-a050-15923006dac0	2022-04-01	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 1 of 2 · 114 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7992	SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-7992	SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7992	SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7993	SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-7993	SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7993	SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8056	SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8056	SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8056	SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
50090-4736	SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	ANDA	Current
50090-4736	SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	ANDA	Current
50090-4901	SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	ANDA	Current
50090-5788	SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	ANDA	Current
50090-6236	SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	ANDA	Current
50090-6306	SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	ANDA	Current
53808-0790	simvastatin	SIMVASTATIN	DOH CENTRAL PHARMACY	ANDA	Current
53808-0791	simvastatin	SIMVASTATIN	DOH CENTRAL PHARMACY	ANDA	Current
53808-0794	simvastatin	SIMVASTATIN	DOH CENTRAL PHARMACY	ANDA	Current
55154-4782	Simvastatin	Simvastatin	Cardinal Health 107, LLC	ANDA	Current
55154-4782	Simvastatin	Simvastatin	Cardinal Health	ANDA	Current
55154-4782	Simvastatin	Simvastatin	Cardinal Health	ANDA	Current
55154-4782	Simvastatin	Simvastatin	Cardinal Health	ANDA	Current
55700-426	SIMVASTATIN	SIMVASTATIN	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-515	SIMVASTATIN	SIMVASTATIN	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
57297-464	SIMVASTATIN	SIMVASTATIN	LUPIN LIMITED	ANDA	Current
57297-465	SIMVASTATIN	SIMVASTATIN	LUPIN LIMITED	ANDA	Current
57297-478	SIMVASTATIN	SIMVASTATIN	LUPIN LIMITED	ANDA	Current
57297-479	SIMVASTATIN	SIMVASTATIN	LUPIN LIMITED	ANDA	Current
57297-480	SIMVASTATIN	SIMVASTATIN	LUPIN LIMITED	ANDA	Current
57297-481	SIMVASTATIN	SIMVASTATIN	LUPIN LIMITED	ANDA	Current
57297-482	SIMVASTATIN	SIMVASTATIN	LUPIN LIMITED	ANDA	Current
60687-210	SIMVASTATIN	SIMVASTATIN	American Health Packaging	ANDA	Current
60687-210	Simvastatin	Simvastatin	American Health Packaging	ANDA	Current
60687-210	Simvastatin	Simvastatin	American Health Packaging	ANDA	Current
60687-210	Simvastatin	Simvastatin	American Health Packaging	ANDA	Current
61919-764	SIMVASTATIN	SIMVASTATIN	DIRECT RX	ANDA	Current
61919-764	SIMVASTATIN	SIMVASTATIN	DIRECT RX	ANDA	Current
61919-764	SIMVASTATIN	SIMVASTATIN	DIRECT RX	ANDA	Current
61919-764	SIMVASTATIN	SIMVASTATIN	DIRECT RX	ANDA	Current
61919-764	SIMVASTATIN	SIMVASTATIN	DIRECT RX	ANDA	Current
68071-2250	SIMVASTATIN	SIMVASTATIN	NuCare Pharmaceuticals.Inc.	ANDA	Current
68071-4331	SIMVASTATIN	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-511	Simvastatin	Simvastatin	American Health Packaging	ANDA	Current
68084-511	Simvastatin	Simvastatin	American Health Packaging	ANDA	Current
68084-511	Simvastatin	Simvastatin	American Health Packaging	ANDA	Current
68084-511	Simvastatin	Simvastatin	American Health Packaging	ANDA	Current
68084-512	Simvastatin	Simvastatin	American Health Packaging	ANDA	Current
68084-512	Simvastatin	Simvastatin	American Health Packaging	ANDA	Current
68084-512	Simvastatin	Simvastatin	American Health Packaging	ANDA	Current
68084-512	Simvastatin	Simvastatin	American Health Packaging	ANDA	Current
68180-464	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-464	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-464	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-464	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-464	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-464	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-465	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-465	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-465	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-465	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-465	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-465	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-478	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-478	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-478	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-478	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-478	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-478	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-479	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-479	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-479	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-479	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-479	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-479	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-480	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-480	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-480	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-480	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-480	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-480	SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	ANDA	Current