Application 018830

Type: NDA
Sponsor: CNTY LINE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAMBOCOR	FLECAINIDE ACETATE	TABLET;ORAL	100MG	Yes	No
002	TAMBOCOR	FLECAINIDE ACETATE	TABLET;ORAL	200MG	No	No
003	TAMBOCOR	FLECAINIDE ACETATE	TABLET;ORAL	150MG	Yes	No
004	TAMBOCOR	FLECAINIDE ACETATE	TABLET;ORAL	50MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N018830-001	TAMBOCOR	FLECAINIDE ACETATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-10-31
N018830-002	TAMBOCOR	FLECAINIDE ACETATE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1985-10-31
N018830-003	TAMBOCOR	FLECAINIDE ACETATE	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-06-03
N018830-004	TAMBOCOR	FLECAINIDE ACETATE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-08-23

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018830-001	TAMBOCOR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018830-002	TAMBOCOR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1985-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018830-003	TAMBOCOR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018830-004	TAMBOCOR	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018830-001	TAMBOCOR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018830-002	TAMBOCOR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1985-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018830-003	TAMBOCOR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018830-004	TAMBOCOR	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018830-001	TAMBOCOR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018830-002	TAMBOCOR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1985-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018830-003	TAMBOCOR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018830-004	TAMBOCOR	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018830-001	TAMBOCOR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018830-002	TAMBOCOR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1985-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018830-003	TAMBOCOR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018830-004	TAMBOCOR	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018830-001	TAMBOCOR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018830-002	TAMBOCOR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1985-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018830-003	TAMBOCOR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018830-004	TAMBOCOR	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018830-001	TAMBOCOR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018830-002	TAMBOCOR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1985-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018830-003	TAMBOCOR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018830-004	TAMBOCOR	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018830-001	TAMBOCOR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018830-002	TAMBOCOR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1985-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018830-003	TAMBOCOR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018830-004	TAMBOCOR	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018830-001	TAMBOCOR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018830-002	TAMBOCOR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1985-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018830-003	TAMBOCOR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018830-004	TAMBOCOR	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018830-001	TAMBOCOR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018830-002	TAMBOCOR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1985-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018830-003	TAMBOCOR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018830-004	TAMBOCOR	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018830-001	TAMBOCOR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018830-002	TAMBOCOR	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		1985-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018830-003	TAMBOCOR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018830-004	TAMBOCOR	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-08-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018830-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018830-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018830-004	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N018830-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018830-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018830-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018830-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018830-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018830-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018830-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018830-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018830-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018830-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018830-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018830-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018830-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018830-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018830-004	AB	1	`ea99ee380514…`

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flecainide Acetate	FLECAINIDE ACETATE	Epic Pharma, LLC	74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	a30103c5-a261-49a5-a7b3-f43eb77e87b7	2026-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	PD-Rx Pharmaceuticals, Inc.	abcb261b-30ae-4eb1-baf0-e9667a2bd8cf	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	PD-Rx Pharmaceuticals, Inc.	2b336028-1e13-4ef7-b75e-345bc9c06f9a	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	PD-Rx Pharmaceuticals, Inc.	45d39dff-22d9-4c04-af26-0cffd41abaa8	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	8a900f29-85e1-464c-ae9e-44dc7cf11f46	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	5cfa10ba-dfe8-42ab-81b3-8cca657aba07	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	b821ec16-93ff-4569-9fbb-4f3842c58bec	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	UNICHEM PHARMACEUTICALS (USA), INC.	5b33e96a-8336-46c4-aac7-4a6c0039cc80	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	AvPAK	f53e1a49-6185-6db4-c867-ffd1241a8cb7	2026-01-11	Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	A-S Medication Solutions	166aa9e4-3402-4ebd-baa5-07a8da8aae56	2026-01-06	Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	A-S Medication Solutions	1a2a5e08-2697-4a00-94fe-de07148acbd9	2025-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	f0416c8c-faae-4e31-aa50-1fb7df10abf0	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	bf810a3b-1a71-4a05-bf54-d5a6caba444b	2025-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Hikma Pharmaceuticals USA Inc.	4f6b78d4-8ac8-464b-bb78-ee70cbc97898	2024-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	A-S Medication Solutions	475a52a9-f18c-4a69-91f0-8f5e601f4336	2024-11-13	Boxed warning, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Chartwell RX, LLC	a604aee4-30d5-4007-9882-98137d0d867f	2024-10-28	Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Amneal Pharmaceuticals LLC	d462d58e-fc3c-4c92-a210-e135eb1f4b77	2024-10-25	Warnings, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	6b73e32f-851b-4503-8296-e5db3a584b75	2024-05-24	Boxed warning, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	2013e6ef-9141-42c3-8ea8-285840ecdd15	2024-04-03	Boxed warning, Adverse reactions	Name fallback generic name: FLECAINIDE ACETATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43199-056	Flecainide acetate	Flecainide acetate	County Line Pharmaceuticals, LLC	NDA	Current
43199-057	Flecainide acetate	Flecainide acetate	County Line Pharmaceuticals, LLC	NDA	Current
43199-058	Flecainide acetate	Flecainide acetate	County Line Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69875	SUPPL	2022-01-13
50349	SUPPL	2017-11-09
57417	ORIG	1985-10-31