Application 017447

Type: NDA
Sponsor: GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORPACE	DISOPYRAMIDE PHOSPHATE	CAPSULE;ORAL	EQ 100MG BASE	Yes	No
002	NORPACE	DISOPYRAMIDE PHOSPHATE	CAPSULE;ORAL	EQ 150MG BASE	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017447-001	NORPACE	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982
N017447-002	NORPACE	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N017447-001	AB
N017447-002	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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017447-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017447-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017447-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017447-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017447-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017447-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017447-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017447-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017447-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017447-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017447-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017447-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017447-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017447-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017447-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017447-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017447-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017447-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017447-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017447-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017447-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017447-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017447-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017447-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017447-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017447-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017447-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017447-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017447-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017447-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017447-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017447-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017447-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017447-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017447-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017447-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017447-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017447-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017447-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017447-002	AB	1	`4b0b4de00fa7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norpace	DISOPYRAMIDE PHOSPHATE	Pfizer Laboratories Div Pfizer Inc	e2aa1642-d262-4520-bc6a-9fd3ad795677	2026-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017447 application number: NDA017447 ndc (product): 0025-2752 ndc (product): 0025-2762
Disopyramide Phosphate	DISOPYRAMIDE PHOSPHATE	Mylan Pharmaceuticals Inc.	31e79459-107f-4d69-a163-90014f1c4772	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017447 application number: NDA017447 ndc (product): 59762-0386 ndc (product): 59762-0400

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0025-2752	Norpace	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2752	Norpace	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2752	Norpace	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2752	Norpace	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2752	Norpace	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2752	Norpace	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2752	Norpace	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2752	Norpace	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2762	Norpace	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2762	Norpace	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2762	Norpace	disopyramide phosphate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-2762	Norpace	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2762	Norpace	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2762	Norpace	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2762	Norpace	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-2762	Norpace	disopyramide phosphate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
59762-0386	Disopyramide Phosphate	disopyramide phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0386	Disopyramide Phosphate	disopyramide phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0400	Disopyramide Phosphate	disopyramide phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0400	Disopyramide Phosphate	disopyramide phosphate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current