Orange Book product · Generic (ANDA)
PROCHLORPERAZINE EDISYLATE
PROCHLORPERAZINE EDISYLATE
At a glance
Sep 28, 2021
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 28, 2021
4 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
PROCHLORPERAZINE EDISYLATE
Strength
EQ 5MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 213626
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PROCHLORPERAZINE EDISYLATE
- —COMPAZINEBrand (NDA)
NDA 011276 · GLAXOSMITHKLINE
- —COMPAZINEBrand (NDA)
NDA 010742 · GLAXOSMITHKLINE
- —COMPAZINEBrand (NDA)
NDA 011188 · 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 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.
