Application 007335

Type: NDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	375MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	INJECTABLE;INJECTION	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N007335-001	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N007335-002	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N007335-003	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N007335-004	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N007335-005	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N007335-001	PRONESTYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N007335-002	PRONESTYL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N007335-003	PRONESTYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N007335-004	PRONESTYL	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N007335-005	PRONESTYL	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N007335-001	PRONESTYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N007335-002	PRONESTYL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N007335-003	PRONESTYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N007335-004	PRONESTYL	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N007335-005	PRONESTYL	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N007335-001	PRONESTYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N007335-002	PRONESTYL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N007335-003	PRONESTYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N007335-004	PRONESTYL	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N007335-005	PRONESTYL	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007335-001	PRONESTYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007335-002	PRONESTYL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007335-003	PRONESTYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007335-004	PRONESTYL	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007335-005	PRONESTYL	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N007335-001	PRONESTYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N007335-002	PRONESTYL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N007335-003	PRONESTYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N007335-004	PRONESTYL	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N007335-005	PRONESTYL	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007335-001	PRONESTYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007335-002	PRONESTYL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007335-003	PRONESTYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007335-004	PRONESTYL	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007335-005	PRONESTYL	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007335-001	PRONESTYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007335-002	PRONESTYL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007335-003	PRONESTYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007335-004	PRONESTYL	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007335-005	PRONESTYL	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007335-001	PRONESTYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007335-002	PRONESTYL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007335-003	PRONESTYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007335-004	PRONESTYL	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007335-005	PRONESTYL	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`03ed91905a0d…`

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
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	REMEDYREPACK INC.	1ec3b767-66bb-4634-877e-71f70d501da0	2026-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Hospira, Inc.	17e47845-daad-434c-a784-6d3875b0d704	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCAINAMIDE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	fece65c0-fdbc-61d8-e053-6294a90a9a68	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Nexus Pharmaceuticals LLC	d58751df-cd8b-45a6-8a32-af19e747e23a	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Medical Purchasing Solutions, LLC.	42405567-3d04-7aec-e063-6294a90aba0a	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	ProPharma Distribution	3d5d9d6e-1f1c-7565-e063-6394a90a93e7	2025-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Caplin Steriles Limited	fcaa5e9a-3c8a-4796-aa87-626268b6cf60	2025-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Sagent Pharmaceuticals	358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Gland Pharma Limited	ffde440f-7ad7-434c-bcd2-9bd8ff16d204	2024-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	0aac32fa-37b7-5520-e063-6394a90a1fe4	2023-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	International Medication Systems, Limited	d7cb1594-61cf-41c4-9007-1ee28aa69c50	2016-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCAINAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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