Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 005845

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BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE)
25MG
Marketing Status: Discontinued

Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE
Proprietary Name: BENADRYL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N005845
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MCNEIL CONSUMER HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information

BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE)
50MG
Marketing Status: Discontinued

Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE
Proprietary Name: BENADRYL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N005845
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MCNEIL CONSUMER HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information

BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE)
12.5MG/5ML
Marketing Status: Discontinued

Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE
Proprietary Name: BENADRYL
Dosage Form; Route of Administration: ELIXIR; ORAL
Strength: 12.5MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N005845
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MCNEIL CONSUMER HEALTHCARE
Marketing Status:  Discontinued
Patent and Exclusivity Information