FDA Orange Book · active-ingredient family
Disopyramide phosphate
Disopyramide phosphate is approved as 2 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NORPACE CR · NDA 018655
2
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, capsule, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NORPACE CRRLD×2 | PFIZER | NDA 018655 | — | Jul 20, 1982 | |
| NORPACERLD×2 | PFIZER | NDA 017447 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DISOPYRAMIDE PHOSPHATE | NESHER PHARMS | ANDA 071200 | — | Dec 15, 1987 | |
| DISOPYRAMIDE PHOSPHATE | SUPERPHARM | ANDA 070940 | — | Feb 09, 1987 | |
| DISOPYRAMIDE PHOSPHATE | SUPERPHARM | ANDA 070941 | — | Feb 09, 1987 | |
| DISOPYRAMIDE PHOSPHATE | INTERPHARM | ANDA 071190 | — | Jan 15, 1987 | |
| DISOPYRAMIDE PHOSPHATE | INTERPHARM | ANDA 071191 | — | Jan 15, 1987 | |
| DISOPYRAMIDE PHOSPHATE | WATSON LABS | ANDA 070240 | — | Feb 02, 1986 | |
| DISOPYRAMIDE PHOSPHATE | WATSON LABS | ANDA 070241 | — | Feb 02, 1986 | |
| DISOPYRAMIDE PHOSPHATE | SUN PHARM INDUSTRIES | ANDA 070351 | — | Dec 17, 1985 | |
| DISOPYRAMIDE PHOSPHATE | SUN PHARM INDUSTRIES | ANDA 070352 | — | Dec 17, 1985 | |
| DISOPYRAMIDE PHOSPHATE | RISING | ANDA 070470 | — | Dec 10, 1985 | |
| DISOPYRAMIDE PHOSPHATE | RISING | ANDA 070471 | — | Dec 10, 1985 | |
| DISOPYRAMIDE PHOSPHATE | IVAX SUB TEVA PHARMS | ANDA 070186 | — | Nov 18, 1985 | |
| DISOPYRAMIDE PHOSPHATE | IVAX SUB TEVA PHARMS | ANDA 070187 | — | Nov 18, 1985 | |
| DISOPYRAMIDE PHOSPHATE | MYLAN | ANDA 070138 | — | Jun 14, 1985 | |
| DISOPYRAMIDE PHOSPHATE | MYLAN | ANDA 070139 | — | Jun 14, 1985 | |
| DISOPYRAMIDE PHOSPHATE×2 | DR REDDYS LABS SA | ANDA 070173 | AB | May 31, 1985 | |
| DISOPYRAMIDE PHOSPHATE | TEVA | ANDA 070101 | AB | Feb 22, 1985 | |
| DISOPYRAMIDE PHOSPHATE | TEVA | ANDA 070102 | AB | Feb 22, 1985 |
Listed patents
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.
Disopyramide phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
