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 1.

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 · 123 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200815-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-10-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200815-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200815-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 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	db3fb41e-ed00-4fa9-b725-b8d9ba731de1	2024-12-06	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815 ndc (product): 63629-2194
Felodipine	FELODIPINE	Bryant Ranch Prepack	3dbc3f1b-37a6-41af-9d4b-a61a12f6260b	2024-12-05	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815 ndc (product): 63629-2193
Felodipine	FELODIPINE	Bryant Ranch Prepack	9b6deb61-f94e-4b21-adc9-37a1d188c9bd	2024-12-05	Adverse reactions	Exact identifier application applno (ANDA): 200815 application number: ANDA200815 ndc (product): 63629-2192
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