Application 203803

Type: ANDA
Sponsor: MYLAN

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A203803-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-29
A203803-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-29
A203803-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-29

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 2 of 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL		2016-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203803-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203803-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203803-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-04-29	`c0c555d07b60…`

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	A203803-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203803-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203803-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203803-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203803-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203803-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203803-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203803-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203803-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203803-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203803-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203803-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203803-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203803-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203803-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203803-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203803-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203803-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203803-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203803-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203803-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203803-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203803-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203803-003	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 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
propafenone hydrochloride	PROPAFENONE HYDROCHLORIDE	Northstar Rx LLC	2ecd6452-ccc3-493f-9a4a-69f0fbf67a42	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: propafenone hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	c8ad1f0f-0e95-4868-a2af-e193c1833841	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROPAFENONE HYDROCHLORIDE generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	faa8e971-4b4f-43db-be97-33acc16dcdc7	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROPAFENONE HYDROCHLORIDE generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	80f174e1-f249-4f34-806d-20e643084429	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROPAFENONE HYDROCHLORIDE generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	A-S Medication Solutions	41b4e503-60a6-4662-a6f9-46ecf93d930a	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	680a803d-3d4d-4ca3-b1ce-7d7e3ff8a626	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	5c8cebcd-699f-4c4c-900b-94e0fe519345	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	739b7624-952d-4343-b720-974d30e284d9	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
propafenone hydrochloride	PROPAFENONE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	d818af31-2535-4595-82fe-fd7abf66fd6c	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: propafenone hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	8aa6f58a-2980-4caa-9c54-d55d69d5d132	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	7202aed6-40a9-2bff-e053-2a95a90ae752	2025-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	a6ac2a70-e0ec-4fcd-8732-5f1637be1e60	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	American Health Packaging	da08c286-b930-463a-858a-efc54f12019f	2025-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROPAFENONE HYDROCHLORIDE generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	617faff7-d9e4-477d-ab2c-aded5c129a86	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	American Health Packaging	343e4ad7-05e2-4e6c-8f8e-91c07739cae2	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	8d1be333-be2b-4064-86a4-c2ad9ad07b83	2025-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	c65253ab-937f-4982-b841-69c2b9f9ccdb	2025-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROPAFENONE HYDROCHLORIDE generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	a96f9c6f-4c9c-4406-bca8-08bf9a4af1f4	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROPAFENONE HYDROCHLORIDE generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	1c4fc726-3f5b-4b12-a66e-727c5133d1d9	2025-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Propafenone Hydrochloride generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE	Vitruvias Therapeutics	bc1d2548-15a3-4986-92b1-c3ddfb35343a	2024-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1258	Propafenone Hydrochloride	propafenone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1259	Propafenone Hydrochloride	propafenone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1261	Propafenone Hydrochloride	propafenone	Mylan Pharmaceuticals Inc.	ANDA	Current