Orange Book product · Brand (NDA)
COMPAZINE
PROCHLORPERAZINE MALEATE
At a glance
Oct 06, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 06, 1999
27 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
PROCHLORPERAZINE MALEATE
Strength
EQ 10MG BASE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021019
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —COMPAZINEBrand (NDA)
NDA 011000 · GLAXOSMITHKLINE
- —COMPAZINEBrand (NDA)
NDA 010571 · 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.
