Application 090365

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FELODIPINE	FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	2.5MG	No	No
002	FELODIPINE	FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	5MG	No	No
003	FELODIPINE	FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090365-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17
A090365-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17
A090365-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090365-001	AB
A090365-002	AB
A090365-003	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 4 · 126 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	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090365-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090365-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090365-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-17	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A090365-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090365-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090365-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090365-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090365-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090365-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090365-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090365-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090365-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090365-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090365-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090365-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090365-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090365-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090365-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090365-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090365-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090365-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090365-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090365-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090365-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090365-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090365-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090365-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090365-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090365-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090365-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090365-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090365-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090365-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090365-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090365-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090365-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090365-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090365-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090365-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090365-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090365-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090365-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090365-001	AB	1	`1e350fbaab3a…`

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
Felodipine	FELODIPINE	Bryant Ranch Prepack	924b2633-74bd-469f-b831-77f09dfebbf7	2026-06-23	Adverse reactions	Exact identifier application applno (ANDA): 090365 application number: ANDA090365 ndc (product): 71335-1486
Felodipine	FELODIPINE	Glenmark Pharmaceuticals Inc., USA	2e4298cf-02e9-49c7-9803-887161e1989a	2026-01-23	Adverse reactions	Exact identifier application applno (ANDA): 090365 application number: ANDA090365 ndc (product): 68462-233 ndc (product): 68462-234 ndc (product): 68462-235

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-445	Felodipine	Felodipine	Medsource Pharmaceuticals	ANDA	Current
50090-2421	Felodipine	Felodipine	A-S Medication Solutions	ANDA	Current
68151-3084	Felodipine	Felodipine	Carilion Materials Management	ANDA	Current
68462-233	Felodipine	Felodipine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-234	Felodipine	Felodipine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-235	Felodipine	Felodipine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
71335-1486	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current