FDA Orange Book · active-ingredient family
Prochlorperazine maleate
Prochlorperazine maleate is approved as 3 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COMPAZINE · NDA 010571
3
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COMPAZINERLD×3 | GLAXOSMITHKLINE | NDA 010571 | — | Approved Prior to Jan 1, 1982 | |
| COMPAZINE×2 | GLAXOSMITHKLINE | NDA 021019 | — | Oct 06, 1999 | |
| COMPAZINE×4 | GLAXOSMITHKLINE | NDA 011000 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROCHLORPERAZINE MALEATE×2 | AUROBINDO PHARMA LTD | ANDA 218734 | AB | Sep 08, 2025 | |
| PROCHLORPERAZINE MALEATE×2 | DR REDDYS LABS SA | ANDA 217847 | AB | May 19, 2025 | |
| PROCHLORPERAZINE MALEATE×2 | LEADING | ANDA 218912 | AB | Sep 30, 2024 | |
| PROCHLORPERAZINE MALEATE×2 | AJANTA PHARMA LTD | ANDA 218515 | AB | May 09, 2024 | |
| PROCHLORPERAZINE MALEATE×2 | AMNEAL | ANDA 216598 | AB | Apr 17, 2023 | |
| PROCHLORPERAZINE MALEATE×2 | BIONPHARMA | ANDA 217478 | AB | Apr 04, 2023 | |
| PROCHLORPERAZINE MALEATE×2 | GLENMARK PHARMS LTD | ANDA 216595 | AB | Mar 17, 2023 | |
| PROCHLORPERAZINE MALEATE×2 | ZYDUS LIFESCIENCES | ANDA 216495 | AB | Aug 08, 2022 | |
| PROCHLORPERAZINE MALEATE×2 | NOVITIUM PHARMA | ANDA 216202 | AB | Jun 13, 2022 | |
| PROCOMP×2 | JUBILANT CADISTA | ANDA 040268 | AB | Feb 27, 1998 | |
| PROCHLORPERAZINE MALEATE×2 | IVAX SUB TEVA PHARMS | ANDA 040162 | — | Jan 20, 1998 | |
| PROCHLORPERAZINE MALEATE×2 | DURAMED PHARMS BARR | ANDA 040207 | — | May 01, 1997 | |
| PROCHLORPERAZINE MALEATE×2 | PHARMOBEDIENT | ANDA 040185 | — | Oct 28, 1996 | |
| PROCHLORPERAZINE MALEATE×3 | CHARTWELL RX | ANDA 040101 | — | Jul 19, 1996 | |
| PROCHLORPERAZINE MALEATE×2 | TEVA PHARMS | ANDA 040120 | — | Jul 11, 1996 | |
| PROCHLORPERAZINE MALEATE | DURAMED PHARMS BARR | ANDA 089484 | — | Jan 20, 1987 | |
| PROCHLORPERAZINE MALEATE | DURAMED PHARMS BARR | ANDA 089485 | — | Jan 20, 1987 | |
| PROCHLORPERAZINE MALEATE | DURAMED PHARMS BARR | ANDA 089486 | — | Jan 20, 1987 | |
| PROCHLORPERAZINE | WATSON LABS | ANDA 085580 | — | Approved Prior to Jan 1, 1982 | |
| PROCHLORPERAZINE | WATSON LABS | ANDA 085178 | — | Approved Prior to Jan 1, 1982 | |
| PROCHLORPERAZINE | WATSON LABS | ANDA 085579 | — | 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 maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
