Application 200895

Type: ANDA
Sponsor: HETERO LABS LTD III

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 1.

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
A200895-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25
A200895-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25
A200895-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25
A200895-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25
A200895-005	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200895-001	AB
A200895-002	AB
A200895-003	AB
A200895-004	AB
A200895-005	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 · 205 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
2026-02-19 14:30 UTC	2026-02	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200895-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200895-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200895-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200895-005	AB	1	`5bbf6a4d5a75…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	XLCare Pharmaceuticals Inc.	433f8a86-5ad3-43db-8e62-c0812dd3d723	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200895 application number: ANDA200895
Simvastatin	SIMVASTATIN	Quallent Pharmaceuticals Health LLC	2b4255a7-f9f5-4235-8dbb-b0f03acbd624	2024-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200895 application number: ANDA200895 ndc (product): 82009-016 ndc (product): 82009-014 ndc (product): 82009-015 ndc (product): 82009-013 ndc (product): 82009-012
Simvastatin	SIMVASTATIN	Camber Pharmaceuticals, Inc.	751b79c6-bba8-4d29-b69c-a2ac6453fec8	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200895 application number: ANDA200895 ndc (product): 31722-514 ndc (product): 31722-513 ndc (product): 31722-511 ndc (product): 31722-512 ndc (product): 31722-510

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-510	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-510	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-510	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-511	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-511	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-511	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-512	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-512	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-512	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-513	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-513	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-513	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-514	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-514	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-514	Simvastatin	Simvastatin	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-3922	Simvastatin	Simvastatin	A-S Medication Solutions	ANDA	Current
50090-3922	Simvastatin	Simvastatin	A-S Medication Solutions	ANDA	Current
68071-3115	Simvastatin	Simvastatin	NuCare Pharmaceuticals, Inc.	ANDA	Current
70934-376	Simvastatin	Simvastatin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-376	Simvastatin	Simvastatin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
82009-012	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-012	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-012	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-012	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-013	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-013	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-013	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-013	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-014	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-014	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-014	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-014	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-015	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-015	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-015	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-015	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-016	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-016	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-016	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-016	Simvastatin	Simvastatin	Quallent Pharmaceuticals Health LLC	ANDA	Current