Application 021416

Type: NDA
Sponsor: GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	225MG	Yes	No
002	RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	325MG	Yes	No
003	RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	425MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
N021416-001	RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04
N021416-002	RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04
N021416-003	RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021416-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021416-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021416-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021416-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021416-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021416-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021416-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021416-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021416-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021416-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021416-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021416-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021416-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021416-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021416-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021416-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021416-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021416-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021416-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021416-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021416-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021416-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021416-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021416-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021416-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021416-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021416-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021416-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021416-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021416-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021416-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021416-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021416-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021416-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021416-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021416-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021416-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021416-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021416-003	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021416-001	AB	1	`a72a2bbeb626…`

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	7bcc5d3b-b2c9-4753-9eef-b5360538f5ee	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	163564b6-a8bf-4258-8ef9-19e33fb2d7bc	2024-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Zydus Lifesciences Limited	b41ec863-5734-41a3-9837-6c0a962ec6eb	2023-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	2492317c-8b04-477e-a5d2-53e791fface9	2023-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	0c887381-42fe-4f37-858a-d9ffb218dd1c	2023-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	36cf4555-6fe9-42d8-8d3b-3ca9c134a5b8	2020-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0173-0823	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0823	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0823	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0823	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0823	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0824	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0824	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0824	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0824	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0824	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0826	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0826	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0826	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0826	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0826	RYTHMOL	propafenone hydrochloride	GlaxoSmithKline LLC	NDA	Current
66993-114	Propafenone Hydrochloride	propafenone hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-114	Propafenone Hydrochloride	propafenone hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-115	Propafenone Hydrochloride	propafenone hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-115	Propafenone Hydrochloride	propafenone hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-116	Propafenone Hydrochloride	propafenone hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-116	Propafenone Hydrochloride	propafenone hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56329	SUPPL	2018-11-07
56253	SUPPL	2018-11-02
15415	SUPPL	2014-06-23
27724	SUPPL	2011-04-19
15414	SUPPL	2011-04-15
27723	SUPPL	2010-11-03
36866	SUPPL	2010-10-29
27722	SUPPL	2004-09-15
42144	ORIG	2004-02-11
36865	ORIG	2003-09-25
5307	ORIG	2003-09-25