Orange Book product · Brand (NDA)
COMPAZINE
PROCHLORPERAZINE EDISYLATE
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 EDISYLATE
Strength
EQ 5MG BASE/5ML
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
NDA 011188
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 011276 · GLAXOSMITHKLINE
- —COMPAZINEBrand (NDA)
NDA 010742 · GLAXOSMITHKLINE
- 2024PROCHLORPERAZINE EDISYLATEGeneric (ANDA)
ANDA 212257 · SOMERSET THERAPS LLC
- 2022PROCHLORPERAZINE EDISYLATEGeneric (ANDA)
ANDA 214192 · AMNEAL
- 2022PROCHLORPERAZINE EDISYLATEGeneric (ANDA)
ANDA 213630 · HIKMA
- 2022PROCHLORPERAZINE EDISYLATEGeneric (ANDA)
ANDA 213873 · EUGIA PHARMA
- 2021PROCHLORPERAZINE EDISYLATEGeneric (ANDA)
ANDA 213626 · VIWIT PHARM
- 2021PROCHLORPERAZINE EDISYLATEGeneric (ANDA)
ANDA 214107 · GLAND
- 2021PROCHLORPERAZINE EDISYLATEGeneric (ANDA)
ANDA 214379 · CAPLIN
- 2019PROCHLORPERAZINE EDISYLATEGeneric (ANDA)
ANDA 204860 · NEXUS
- 2018PROCHLORPERAZINE EDISYLATEGeneric (ANDA)
ANDA 210710 · MYLAN LABS LTD
- 2013PROCHLORPERAZINE EDISYLATEGeneric (ANDA)
ANDA 204147 · AVET LIFESCIENCES
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.
