Product Details for NDA 007638
CHLOR-TRIMETON (CHLORPHENIRAMINE MALEATE)
8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPHENIRAMINE MALEATE
Proprietary Name: CHLOR-TRIMETON
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N007638
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
CHLOR-TRIMETON (CHLORPHENIRAMINE MALEATE)
Proprietary Name: CHLOR-TRIMETON
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N007638
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPHENIRAMINE MALEATE
Proprietary Name: CHLOR-TRIMETON
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N007638
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CHLOR-TRIMETON
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12MG **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: N007638
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information