Product Details for NDA 010571
COMPAZINE (PROCHLORPERAZINE MALEATE)
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PROCHLORPERAZINE MALEATE
Proprietary Name: COMPAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N010571
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
COMPAZINE (PROCHLORPERAZINE MALEATE)
Proprietary Name: COMPAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N010571
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PROCHLORPERAZINE MALEATE
Proprietary Name: COMPAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N010571
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
COMPAZINE (PROCHLORPERAZINE MALEATE)
Proprietary Name: COMPAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N010571
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PROCHLORPERAZINE MALEATE
Proprietary Name: COMPAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N010571
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: COMPAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N010571
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information