Application 075938

Type: ANDA
Sponsor: VINTAGE 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	Yes

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	RLD / RS	Approval date
A075938-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17
A075938-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17
A075938-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075938-001	AB
A075938-002	AB
A075938-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`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	A075938-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075938-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075938-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075938-001	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	American Health Packaging	da08c286-b930-463a-858a-efc54f12019f	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	American Health Packaging	343e4ad7-05e2-4e6c-8f8e-91c07739cae2	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938 ndc (product): 60687-709
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	c65253ab-937f-4982-b841-69c2b9f9ccdb	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	a96f9c6f-4c9c-4406-bca8-08bf9a4af1f4	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938 ndc (product): 64380-164 ndc (product): 64380-163 ndc (product): 64380-165

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-5448	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
0603-5448	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
0603-5448	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
0603-5448	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-5449	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
0603-5449	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
0603-5449	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
0603-5449	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-5450	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
0603-5450	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
0603-5450	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
0603-5450	Propafenone Hydrochloride	Propafenone Hydrochloride	Par Pharmaceutical	ANDA	Current
0615-7574	Propafenone Hydrochloride	Propafenone Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
50090-1134	Propafenone Hydrochloride	Propafenone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1134	Propafenone Hydrochloride	Propafenone Hydrochloride	A-S Medication Solutions	ANDA	Current
60687-537	Propafenone Hydrochloride	Propafenone Hydrochloride	American Health Packaging	ANDA	Current
60687-537	Propafenone Hydrochloride	Propafenone Hydrochloride	American Health Packaging	ANDA	Current
60687-537	Propafenone Hydrochloride	Propafenone Hydrochloride	American Health Packaging	ANDA	Current
60687-709	Propafenone Hydrochloride	Propafenone Hydrochloride	American Health Packaging	ANDA	Current
63629-2265	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2265	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2266	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2266	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2267	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2267	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2268	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2268	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
64380-163	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current
64380-163	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current
64380-164	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current
64380-164	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current
64380-165	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current
64380-165	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current