Application 090383

Type: ANDA
Sponsor: MICRO LABS

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
A090383-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16
A090383-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16
A090383-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16
A090383-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16
A090383-005	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090383-001	AB
A090383-002	AB
A090383-003	AB
A090383-004	AB
A090383-005	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	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090383-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2011-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090383-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2011-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090383-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2011-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090383-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2011-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090383-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2011-09-16	`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	A090383-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090383-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090383-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090383-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090383-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090383-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090383-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090383-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090383-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090383-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090383-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090383-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090383-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090383-005	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	Micro Labs Limited	5c1c694c-4b08-469e-b538-08e69df06146	2023-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090383 application number: ANDA090383 ndc (product): 42571-020 ndc (product): 42571-040 ndc (product): 42571-010 ndc (product): 42571-080 ndc (product): 42571-005

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-005	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-005	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-005	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-005	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-005	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-005	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-005	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-010	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-010	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-010	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-010	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-010	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-010	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-010	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-020	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-020	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-020	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-020	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-020	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-020	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-020	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-040	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-040	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-040	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-040	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-040	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-040	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-040	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-080	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-080	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-080	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-080	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-080	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-080	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current
42571-080	Simvastatin	Simvastatin	Micro Labs Limited	ANDA	Current