Product Details for NDA 011000
COMPAZINE (PROCHLORPERAZINE MALEATE)
EQ 10MG BASE
Marketing Status: Discontinued
EQ 15MG BASE
Marketing Status: Discontinued
EQ 30MG BASE
Marketing Status: Discontinued
EQ 75MG BASE
Marketing Status: Discontinued
EQ 10MG BASE
Marketing Status: Discontinued
Active Ingredient: PROCHLORPERAZINE MALEATE
Proprietary Name: COMPAZINE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N011000
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: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N011000
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 15MG BASE
Marketing Status: Discontinued
Active Ingredient: PROCHLORPERAZINE MALEATE
Proprietary Name: COMPAZINE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N011000
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: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N011000
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 30MG BASE
Marketing Status: Discontinued
Active Ingredient: PROCHLORPERAZINE MALEATE
Proprietary Name: COMPAZINE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N011000
Product Number: 003
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: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N011000
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 75MG BASE
Marketing Status: Discontinued
Active Ingredient: PROCHLORPERAZINE MALEATE
Proprietary Name: COMPAZINE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N011000
Product Number: 004
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: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N011000
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information