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Product Details for NDA 009149

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THORAZINE (CHLORPROMAZINE)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPROMAZINE
Proprietary Name: THORAZINE
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N009149
Product Number: 024
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
THORAZINE (CHLORPROMAZINE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPROMAZINE
Proprietary Name: THORAZINE
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N009149
Product Number: 033
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
THORAZINE (CHLORPROMAZINE HYDROCHLORIDE)
30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPROMAZINE HYDROCHLORIDE
Proprietary Name: THORAZINE
Dosage Form; Route of Administration: CONCENTRATE; ORAL
Strength: 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N009149
Product Number: 032
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
THORAZINE (CHLORPROMAZINE HYDROCHLORIDE)
100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPROMAZINE HYDROCHLORIDE
Proprietary Name: THORAZINE
Dosage Form; Route of Administration: CONCENTRATE; ORAL
Strength: 100MG/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: N009149
Product Number: 043
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
THORAZINE (CHLORPROMAZINE HYDROCHLORIDE)
25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPROMAZINE HYDROCHLORIDE
Proprietary Name: THORAZINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 25MG/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: N009149
Product Number: 011
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
THORAZINE (CHLORPROMAZINE HYDROCHLORIDE)
10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPROMAZINE HYDROCHLORIDE
Proprietary Name: THORAZINE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 10MG/5ML **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: N009149
Product Number: 022
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
THORAZINE (CHLORPROMAZINE HYDROCHLORIDE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPROMAZINE HYDROCHLORIDE
Proprietary Name: THORAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N009149
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
THORAZINE (CHLORPROMAZINE HYDROCHLORIDE)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPROMAZINE HYDROCHLORIDE
Proprietary Name: THORAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N009149
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
THORAZINE (CHLORPROMAZINE HYDROCHLORIDE)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPROMAZINE HYDROCHLORIDE
Proprietary Name: THORAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N009149
Product Number: 013
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
THORAZINE (CHLORPROMAZINE HYDROCHLORIDE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPROMAZINE HYDROCHLORIDE
Proprietary Name: THORAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N009149
Product Number: 018
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
THORAZINE (CHLORPROMAZINE HYDROCHLORIDE)
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPROMAZINE HYDROCHLORIDE
Proprietary Name: THORAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N009149
Product Number: 020
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
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