Application 202445

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A202445-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11
A202445-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11
A202445-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202445-001	AB
A202445-002	AB
A202445-003	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	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`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	A202445-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202445-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202445-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202445-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202445-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202445-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202445-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202445-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202445-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202445-001	AB	1	`8072bd15b7f6…`

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 1 · 4 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	c8ad1f0f-0e95-4868-a2af-e193c1833841	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202445 application number: ANDA202445
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	faa8e971-4b4f-43db-be97-33acc16dcdc7	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202445 application number: ANDA202445
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	80f174e1-f249-4f34-806d-20e643084429	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202445 application number: ANDA202445
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	0c887381-42fe-4f37-858a-d9ffb218dd1c	2023-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202445 application number: ANDA202445 ndc (product): 59651-257 ndc (product): 59651-258 ndc (product): 59651-256

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-256	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-256	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-256	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-257	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-257	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-257	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-258	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-258	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-258	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current