FDA Orange Book · active-ingredient family
Prochlorperazine edisylate
Prochlorperazine edisylate is approved as 3 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COMPAZINE · NDA 011276
3
Brand (NDA)
26
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · concentrate, injectable, syrup
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COMPAZINERLD | GLAXOSMITHKLINE | NDA 011276 | — | Approved Prior to Jan 1, 1982 | |
| COMPAZINERLD | GLAXOSMITHKLINE | NDA 010742 | — | Approved Prior to Jan 1, 1982 | |
| COMPAZINE | GLAXOSMITHKLINE | NDA 011188 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROCHLORPERAZINE EDISYLATE | SOMERSET THERAPS LLC | ANDA 212257 | AP | Sep 13, 2024 | |
| PROCHLORPERAZINE EDISYLATE | AMNEAL | ANDA 214192 | — | Nov 28, 2022 | |
| PROCHLORPERAZINE EDISYLATE | HIKMA | ANDA 213630 | — | Nov 22, 2022 | |
| PROCHLORPERAZINE EDISYLATE | EUGIA PHARMA | ANDA 213873 | AP | Jul 14, 2022 | |
| PROCHLORPERAZINE EDISYLATE | VIWIT PHARM | ANDA 213626 | AP | Sep 28, 2021 | |
| PROCHLORPERAZINE EDISYLATE | GLAND | ANDA 214107 | AP | Sep 22, 2021 | |
| PROCHLORPERAZINE EDISYLATE | CAPLIN | ANDA 214379 | AP | Apr 22, 2021 | |
| PROCHLORPERAZINE EDISYLATE | NEXUS | ANDA 204860 | — | Feb 15, 2019 | |
| PROCHLORPERAZINE EDISYLATE | MYLAN LABS LTD | ANDA 210710 | AP | Oct 25, 2018 | |
| PROCHLORPERAZINE EDISYLATE | AVET LIFESCIENCES | ANDA 204147 | AP | Oct 15, 2013 | |
| PROCHLORPERAZINE EDISYLATE | SAGENT | ANDA 040540 | AP | May 28, 2004 | |
| PROCHLORPERAZINE EDISYLATE | TEVA PARENTERAL | ANDA 040505 | — | May 30, 2003 | |
| PROCHLORPERAZINE EDISYLATE | HIKMA | ANDA 089903 | AP | Aug 29, 1989 | |
| PROCHLORPERAZINE EDISYLATE | MARSAM PHARMS LLC | ANDA 089675 | — | Dec 05, 1988 | |
| PROCHLORPERAZINE EDISYLATE | HIKMA | ANDA 089523 | — | May 03, 1988 | |
| PROCHLORPERAZINE EDISYLATE | HOSPIRA | ANDA 089703 | — | Apr 07, 1988 | |
| PROCHLORPERAZINE EDISYLATE | WATSON LABS | ANDA 089530 | — | Jul 08, 1987 | |
| PROCHLORPERAZINE EDISYLATE | WATSON LABS | ANDA 089605 | — | Jul 08, 1987 | |
| PROCHLORPERAZINE EDISYLATE | WATSON LABS | ANDA 089606 | — | Jul 08, 1987 | |
| PROCHLORPERAZINE EDISYLATE | SMITH AND NEPHEW | ANDA 089251 | — | Dec 04, 1986 | |
| PROCHLORPERAZINE EDISYLATE | MORTON GROVE | ANDA 088598 | — | Oct 25, 1984 | |
| PROCHLORPERAZINE EDISYLATE | MORTON GROVE | ANDA 088597 | — | Oct 25, 1984 | |
| PROCHLORPERAZINE | BAXTER HLTHCARE | ANDA 087759 | — | Oct 01, 1982 | |
| PROCHLORPERAZINE EDISYLATE | ALPHARMA US PHARMS | ANDA 087154 | — | Sep 01, 1982 | |
| PROCHLORPERAZINE | ALPHARMA US PHARMS | ANDA 087153 | — | Jun 08, 1982 | |
| PROCHLORPERAZINE EDISYLATE | WYETH AYERST | ANDA 086348 | — | Approved Prior to Jan 1, 1982 |
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.
Prochlorperazine edisylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
