Product Details for NDA 010799
DIMETANE (BROMPHENIRAMINE MALEATE)
4MG
Marketing Status: Discontinued
8MG
Marketing Status: Discontinued
12MG
Marketing Status: Discontinued
4MG
Marketing Status: Discontinued
Active Ingredient: BROMPHENIRAMINE MALEATE
Proprietary Name: DIMETANE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N010799
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH CONSUMER HEALTHCARE
Marketing Status: Discontinued
Patent and Exclusivity Information
DIMETANE (BROMPHENIRAMINE MALEATE)
Proprietary Name: DIMETANE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N010799
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WYETH CONSUMER HEALTHCARE
Marketing Status: Discontinued
Patent and Exclusivity Information
8MG
Marketing Status: Discontinued
Active Ingredient: BROMPHENIRAMINE MALEATE
Proprietary Name: DIMETANE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N010799
Product Number: 010
Approval Date: Jun 10, 1983
Applicant Holder Full Name: WYETH CONSUMER HEALTHCARE
Marketing Status: Discontinued
Patent and Exclusivity Information
DIMETANE (BROMPHENIRAMINE MALEATE)
Proprietary Name: DIMETANE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N010799
Product Number: 010
Approval Date: Jun 10, 1983
Applicant Holder Full Name: WYETH CONSUMER HEALTHCARE
Marketing Status: Discontinued
Patent and Exclusivity Information
12MG
Marketing Status: Discontinued
Active Ingredient: BROMPHENIRAMINE MALEATE
Proprietary Name: DIMETANE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N010799
Product Number: 011
Approval Date: Jun 10, 1983
Applicant Holder Full Name: WYETH CONSUMER HEALTHCARE
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DIMETANE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N010799
Product Number: 011
Approval Date: Jun 10, 1983
Applicant Holder Full Name: WYETH CONSUMER HEALTHCARE
Marketing Status: Discontinued
Patent and Exclusivity Information