Application 209222

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;10MG	No	No
002	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;20MG	No	No
003	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;40MG	No	No
004	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209222-001	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-12-22
A209222-002	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-12-22
A209222-003	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-12-22
A209222-004	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A209222-001	AB
A209222-002	AB
A209222-003	AB
A209222-004	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 5 · 168 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	A209222-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209222-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209222-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209222-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209222-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209222-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209222-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209222-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209222-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209222-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209222-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209222-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209222-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209222-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209222-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209222-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209222-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209222-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209222-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209222-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209222-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209222-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209222-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209222-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209222-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209222-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209222-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209222-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209222-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209222-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209222-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209222-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209222-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209222-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209222-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209222-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209222-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209222-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209222-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209222-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A209222-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209222-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209222-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209222-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209222-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209222-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209222-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209222-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209222-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209222-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209222-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209222-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209222-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209222-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209222-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209222-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209222-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209222-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209222-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209222-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209222-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209222-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209222-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209222-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209222-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209222-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209222-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209222-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209222-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209222-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209222-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209222-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209222-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209222-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209222-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209222-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209222-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209222-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209222-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209222-004	AB	1	`d8e5a09893c0…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe and Simvastatin	EZETIMIBE AND SIMVASTATIN	A-S Medication Solutions	2ce219a2-1eeb-4ece-bb87-3810e593ca51	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209222 application number: ANDA209222 ndc (product): 50090-4772
Ezetimibe and Simvastatin	EZETIMIBE AND SIMVASTATIN	Ascend Laboratories, LLC	c90e8c96-e130-42d7-bf0d-5833652e40d5	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209222 application number: ANDA209222 ndc (product): 67877-507 ndc (product): 67877-508 ndc (product): 67877-510 ndc (product): 67877-509

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4772	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	A-S Medication Solutions	ANDA	Current
50090-4772	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	A-S Medication Solutions	ANDA	Current
67877-507	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-507	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-507	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-507	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-507	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-508	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-508	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-508	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-508	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-508	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-509	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-509	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-509	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-509	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-509	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-510	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-510	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-510	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-510	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
67877-510	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	Ascend Laboratories, LLC	ANDA	Current
70518-1850	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	REMEDYREPACK INC.	ANDA	Current
70518-1955	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	REMEDYREPACK INC.	ANDA	Current
70518-1955	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	REMEDYREPACK INC.	ANDA	Current
70518-1955	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	REMEDYREPACK INC.	ANDA	Current
70518-1955	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	REMEDYREPACK INC.	ANDA	Current
70518-1955	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	REMEDYREPACK INC.	ANDA	Current
70518-1955	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	REMEDYREPACK INC.	ANDA	Current
70518-1955	Ezetimibe and Simvastatin	Ezetimibe and Simvastatin	REMEDYREPACK INC.	ANDA	Current