Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 011552

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STELAZINE (TRIFLUOPERAZINE HYDROCHLORIDE)
EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: TRIFLUOPERAZINE HYDROCHLORIDE
Proprietary Name: STELAZINE
Dosage Form; Route of Administration: CONCENTRATE; ORAL
Strength: EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N011552
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information

STELAZINE (TRIFLUOPERAZINE HYDROCHLORIDE)
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: TRIFLUOPERAZINE HYDROCHLORIDE
Proprietary Name: STELAZINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N011552
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information

STELAZINE (TRIFLUOPERAZINE HYDROCHLORIDE)
EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: TRIFLUOPERAZINE HYDROCHLORIDE
Proprietary Name: STELAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N011552
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information

STELAZINE (TRIFLUOPERAZINE HYDROCHLORIDE)
EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: TRIFLUOPERAZINE HYDROCHLORIDE
Proprietary Name: STELAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG 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: N011552
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information

STELAZINE (TRIFLUOPERAZINE HYDROCHLORIDE)
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: TRIFLUOPERAZINE HYDROCHLORIDE
Proprietary Name: STELAZINE
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: N011552
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information

STELAZINE (TRIFLUOPERAZINE HYDROCHLORIDE)
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: TRIFLUOPERAZINE HYDROCHLORIDE
Proprietary Name: STELAZINE
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: N011552
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information