Application 200815

Type: ANDA
Sponsor: VINTAGE PHARMS LLC

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
A200815-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28
A200815-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28
A200815-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200815-001	AB
A200815-002	AB
A200815-003	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	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`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	A200815-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200815-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200815-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200815-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200815-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200815-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200815-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200815-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200815-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200815-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200815-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200815-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200815-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200815-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200815-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200815-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200815-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200815-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200815-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200815-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200815-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felodipine	FELODIPINE	Bryant Ranch Prepack	b27a13d4-c068-43c8-b654-b8b3276e468a	2024-12-06	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815 ndc (product): 63629-2196
Felodipine	FELODIPINE	Bryant Ranch Prepack	45e3094c-7755-48c2-be65-c0377f18a400	2024-12-05	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815 ndc (product): 63629-2191
Felodipine	FELODIPINE	Endo USA, Inc.	55637724-8757-11de-8a39-0800200c9a66	2024-09-30	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815 ndc (product): 0603-3582 ndc (product): 0603-3583 ndc (product): 0603-3581
Felodipine	FELODIPINE	Bryant Ranch Prepack	05feb0a1-8a0c-4d8a-9b86-5e700ea6fd64	2023-12-04	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815 ndc (product): 63629-2195
Felodipine	FELODIPINE	Bryant Ranch Prepack	30d15f4b-a0ee-4841-ace3-dcaf52016953	2023-03-30	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815
Felodipine	FELODIPINE	Bryant Ranch Prepack	196ef773-8a2a-4ef7-a403-2341f94f4d98	2023-03-30	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-3581	Felodipine	Felodipine	Par Pharmaceutical, Inc.	ANDA	Current
0603-3581	Felodipine	Felodipine	Par Pharmaceutical	ANDA	Current
0603-3581	Felodipine	Felodipine	Par Pharmaceutical	ANDA	Current
0603-3582	Felodipine	Felodipine	Par Pharmaceutical, Inc.	ANDA	Current
0603-3582	Felodipine	Felodipine	Par Pharmaceutical	ANDA	Current
0603-3582	Felodipine	Felodipine	Par Pharmaceutical	ANDA	Current
0603-3583	Felodipine	Felodipine	Par Pharmaceutical, Inc.	ANDA	Current
0603-3583	Felodipine	Felodipine	Par Pharmaceutical	ANDA	Current
0603-3583	Felodipine	Felodipine	Par Pharmaceutical	ANDA	Current
63629-2191	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2191	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2192	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2192	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2193	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2193	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2194	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2194	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2195	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2195	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2196	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2196	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current