Application 071200

Type: ANDA
Sponsor: NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 150MG BASE	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071200-001	DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1987-12-15

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A071200-001	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1987-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071200-001	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1987-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071200-001	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1987-12-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A071200-001	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1987-12-15	`a50c72e98297…`

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
Norpace	DISOPYRAMIDE PHOSPHATE	Pfizer Laboratories Div Pfizer Inc	e2aa1642-d262-4520-bc6a-9fd3ad795677	2026-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DISOPYRAMIDE PHOSPHATE
Disopyramide Phosphate	DISOPYRAMIDE PHOSPHATE	Mylan Pharmaceuticals Inc.	31e79459-107f-4d69-a163-90014f1c4772	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Disopyramide Phosphate generic name: DISOPYRAMIDE PHOSPHATE
Disopyramide Phosphate	DISOPYRAMIDE PHOSPHATE	Teva Pharmaceuticals USA, Inc.	11a68e26-d2e4-48f6-ba0f-9bdd5778f25a	2024-09-25	Warnings, Adverse reactions	Name fallback brand name: Disopyramide Phosphate generic name: DISOPYRAMIDE PHOSPHATE
DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	Dr. Reddy's Labratories Inc.	3acbcef2-04ec-1ab1-b855-d1244b0e8006	2024-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DISOPYRAMIDE PHOSPHATE generic name: DISOPYRAMIDE PHOSPHATE

Reported adverse events (FAERS/openFDA)#

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