Application 076550

Type: ANDA
Sponsor: ANI PHARMS INC

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
A076550-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23
A076550-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23
A076550-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076550-001	AB
A076550-002	AB
A076550-003	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	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`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	A076550-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076550-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076550-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076550-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076550-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076550-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076550-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076550-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076550-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076550-001	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	A-S Medication Solutions	41b4e503-60a6-4662-a6f9-46ecf93d930a	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550 ndc (product): 50090-4227
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	680a803d-3d4d-4ca3-b1ce-7d7e3ff8a626	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	5c8cebcd-699f-4c4c-900b-94e0fe519345	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	739b7624-952d-4343-b720-974d30e284d9	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	7202aed6-40a9-2bff-e053-2a95a90ae752	2025-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550 ndc (product): 51407-015 ndc (product): 51407-016 ndc (product): 51407-017
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	a6ac2a70-e0ec-4fcd-8732-5f1637be1e60	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550 ndc (product): 63629-9280
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	617faff7-d9e4-477d-ab2c-aded5c129a86	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	8d1be333-be2b-4064-86a4-c2ad9ad07b83	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550 ndc (product): 62559-231 ndc (product): 62559-230 ndc (product): 62559-232
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	9da7e6d2-64da-43cd-9575-b2b0d5d412dc	2024-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550 ndc (product): 63629-2105
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	7bcc5d3b-b2c9-4753-9eef-b5360538f5ee	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550 ndc (product): 63629-1989
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	2492317c-8b04-477e-a5d2-53e791fface9	2023-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550 ndc (product): 63629-1988

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
50090-4227	Propafenone Hydrochloride	Propafenone Hydrochloride	A-S Medication Solutions	ANDA	Current
51407-015	Propafenone Hydrochloride	Propafenone Hydrochloride	Golden State Medical Supply Inc.	ANDA	Current
51407-015	Propafenone Hydrochloride	Propafenone Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-016	Propafenone Hydrochloride	Propafenone Hydrochloride	Golden State Medical Supply Inc.	ANDA	Current
51407-016	Propafenone Hydrochloride	Propafenone Hydrochloride	Golden State Medical Supply	ANDA	Current
51407-016	Propafenone Hydrochloride	Propafenone Hydrochloride	Golden State Medical Supply	ANDA	Current
51407-016	Propafenone Hydrochloride	Propafenone Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-017	Propafenone Hydrochloride	Propafenone Hydrochloride	Golden State Medical Supply Inc.	ANDA	Current
51407-017	Propafenone Hydrochloride	Propafenone Hydrochloride	Golden State Medical Supply	ANDA	Current
51407-017	Propafenone Hydrochloride	Propafenone Hydrochloride	Golden State Medical Supply	ANDA	Current
51407-017	Propafenone Hydrochloride	Propafenone Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
62559-230	Propafenone Hydrochloride	Propafenone Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-231	Propafenone Hydrochloride	Propafenone Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-232	Propafenone Hydrochloride	Propafenone Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
63629-1988	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1988	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1989	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1989	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2105	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2105	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9280	Propafenone Hydrochloride	Propafenone Hydrochloride	Bryant Ranch Prepack	ANDA	Current