Application 076193

Type: ANDA
Sponsor: NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No
002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	TABLET;ORAL	225MG	No	No
003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	TABLET;ORAL	300MG	No	No

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	Approval date
A076193-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07
A076193-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07
A076193-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076193-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	2002-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076193-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	2002-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076193-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	2002-02-07	`301d65b070ca…`

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 · 27 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	9da7e6d2-64da-43cd-9575-b2b0d5d412dc	2024-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	7bcc5d3b-b2c9-4753-9eef-b5360538f5ee	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride 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 brand name: Propafenone Hydrochloride 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 brand name: Propafenone Hydrochloride 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 brand name: Propafenone Hydrochloride 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 brand name: PROPAFENONE HYDROCHLORIDE 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 brand name: PROPAFENONE HYDROCHLORIDE generic name: PROPAFENONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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