Orange Book product · Brand (NDA)
COMPAZINE
PROCHLORPERAZINE MALEATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PROCHLORPERAZINE MALEATE
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 010571
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1999COMPAZINEBrand (NDA)
NDA 021019 · GLAXOSMITHKLINE
- —COMPAZINEBrand (NDA)
NDA 011000 · GLAXOSMITHKLINE
- 2025PROCHLORPERAZINE MALEATEGeneric (ANDA)
ANDA 218734 · AUROBINDO PHARMA LTD
- 2025PROCHLORPERAZINE MALEATEGeneric (ANDA)
ANDA 217847 · DR REDDYS LABS SA
- 2024PROCHLORPERAZINE MALEATEGeneric (ANDA)
ANDA 218912 · LEADING
- 2024PROCHLORPERAZINE MALEATEGeneric (ANDA)
ANDA 218515 · AJANTA PHARMA LTD
- 2023PROCHLORPERAZINE MALEATEGeneric (ANDA)
ANDA 216598 · AMNEAL
- 2023PROCHLORPERAZINE MALEATEGeneric (ANDA)
ANDA 217478 · BIONPHARMA
- 2023PROCHLORPERAZINE MALEATEGeneric (ANDA)
ANDA 216595 · GLENMARK PHARMS LTD
- 2022PROCHLORPERAZINE MALEATEGeneric (ANDA)
ANDA 216495 · ZYDUS LIFESCIENCES
- 2022PROCHLORPERAZINE MALEATEGeneric (ANDA)
ANDA 216202 · NOVITIUM PHARMA
- 1998PROCOMPGeneric (ANDA)
ANDA 040268 · JUBILANT CADISTA
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.
