FDA Orange Book · active-ingredient family
Disopyramide phosphate
Disopyramide phosphate: 2 brands, 18 generics; first approved Jul 20, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
18
Listed patents
0
Presentations
23
Brand (NDA) products
Originator applications
- NORPACE CRRLDPFIZERNDA 01865519822 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx — EQ 150MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx — - NORPACERLDPFIZERNDA 017447—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB
Generic (ANDA) products (18)
Abbreviated applications
- DISOPYRAMIDE PHOSPHATENESHER PHARMSANDA 0712001987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATESUPERPHARMANDA 0709401987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATESUPERPHARMANDA 0709411987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATEINTERPHARMANDA 0711901987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATEINTERPHARMANDA 0711911987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATEWATSON LABSANDA 0702401986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATEWATSON LABSANDA 0702411986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATESUN PHARM INDUSTRIESANDA 0703511985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATESUN PHARM INDUSTRIESANDA 0703521985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATERISINGANDA 0704701985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATERISINGANDA 0704711985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATEIVAX SUB TEVA PHARMSANDA 0701861985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATEIVAX SUB TEVA PHARMSANDA 0701871985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATEMYLANANDA 0701381985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATEMYLANANDA 0701391985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Discontinued — - DISOPYRAMIDE PHOSPHATEDR REDDYS LABS SAANDA 07017319852 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB - DISOPYRAMIDE PHOSPHATETEVAANDA 0701011985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Rx AB - DISOPYRAMIDE PHOSPHATETEVAANDA 0701021985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
44 yr 9 mo ago
Most recent approval
39 yr 3 mo ago
Approvals span 1982–1987 across 20 FDA applications.
Brand (NDA) 210%
Generic (ANDA) 1890%
Disopyramide phosphate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
