Application 078034

Type: ANDA
Sponsor: BIOCON LIMITED

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 42.

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
A078034-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20
A078034-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20
A078034-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20
A078034-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20
A078034-005	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078034-001	AB
A078034-002	AB
A078034-003	AB
A078034-004	AB
A078034-005	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 · 210 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
2026-08-18 06:07:40	2026-07	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078034-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078034-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078034-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078034-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078034-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078034-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078034-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078034-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078034-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078034-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078034-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078034-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078034-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078034-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078034-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078034-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078034-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078034-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078034-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078034-005	AB	1	`2680178bc6a6…`

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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	58cd6c9a-3429-24eb-e063-6394a90a6984	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	55f92c72-e690-85dd-e063-6394a90adb39	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	522d0f7f-f20b-bc17-e063-6294a90a3648	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	d053fee4-b797-4a82-8865-0b4d08b14990	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	807e5be4-6f87-48b4-8a3b-e4ad1061e706	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Golden State Medical Supply, Inc.	4cc35f5f-2d3e-dedd-e063-6294a90a5cbe	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f68e9cf8-a63f-1d64-e053-2a95a90a4923	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f2f5ee7a-4f4e-12e9-e053-2a95a90a7eae	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	593f0007-9690-4de5-b1e9-59299e587643	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	4277e75a-7f3b-4f35-ae56-0bbe095586a5	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034 ndc (product): 71335-1905
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	440dff4b-c377-48f3-bf24-07fd986b6fee	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034 ndc (product): 71335-1906
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	14bd8444-1556-4636-9e56-28da21a852fc	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034 ndc (product): 71335-1891
Simvastatin	SIMVASTATIN	Biocon Pharma Inc,	7b325108-6940-50a7-96b4-822a5206e568	2023-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034 ndc (product): 70377-004 ndc (product): 70377-003 ndc (product): 70377-005 ndc (product): 70377-001 ndc (product): 70377-002
Simvastatin	SIMVASTATIN	A-S Medication Solutions	34c8c080-97b5-4580-b8fb-3fd557cdb40a	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	c0a303c5-6277-47ce-bb8a-bd5400fd8261	2023-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034 ndc (product): 71610-609 ndc (product): 71610-611 ndc (product): 71610-610
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	a753846e-4cd5-4ddc-a4f2-c45da571c883	2021-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034 ndc (product): 71610-622 ndc (product): 71610-623
Simvastatin	SIMVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	37860f3f-984e-419a-a262-3bacc766953e	2021-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078034 application number: ANDA078034 ndc (product): 71610-615

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 77 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24658-500	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-500	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-501	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-501	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-502	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-502	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-502	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-503	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-503	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-503	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-504	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-504	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
24658-504	Simvastatin	Simvastatin	PuraCap Laboratories, LLC	ANDA	Current
43353-768	Simvastatin	Simvastatin	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
43353-773	Simvastatin	Simvastatin	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
53808-0927	Simvastatin	Simvastatin	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0952	Simvastatin	Simvastatin	State of Florida DOH Central Pharmacy	ANDA	Current
53808-1078	Simvastatin	Simvastatin	State of Florida DOH Central Pharmacy	ANDA	Current
55154-9525	Simvastatin	Simvastatin	Cardinal Health	ANDA	Current
63629-1196	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1196	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1196	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1197	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1197	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1197	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1198	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1198	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1198	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1199	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1199	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1199	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1200	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1200	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
63629-1200	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
65727-065	Simvastatin	Simvastatin	Biocon Limited	ANDA	Current
65727-066	Simvastatin	Simvastatin	Biocon Limited	ANDA	Current
65727-067	Simvastatin	Simvastatin	Biocon Limited	ANDA	Current
65727-068	Simvastatin	Simvastatin	Biocon Limited	ANDA	Current
65727-069	Simvastatin	Simvastatin	Biocon Limited	ANDA	Current
70377-001	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-001	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-001	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-001	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-001	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-002	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-002	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-002	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-002	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-002	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-003	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-003	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-003	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-003	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-003	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-004	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-004	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-004	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-004	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-004	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-005	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-005	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-005	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-005	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
70377-005	Simvastatin	Simvastatin	Biocon Pharma Inc,	ANDA	Current
71335-1891	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
71335-1891	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
71335-1905	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
71335-1905	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
71335-1906	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
71335-1906	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
71335-2147	Simvastatin	Simvastatin	Bryant Ranch Prepack	ANDA	Current
71610-609	Simvastatin	Simvastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-610	Simvastatin	Simvastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-611	Simvastatin	Simvastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-615	Simvastatin	Simvastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-622	Simvastatin	Simvastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-623	Simvastatin	Simvastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44371	ORIG	2011-05-26