Product Details for NDA 008381
PROMETHAZINE HYDROCHLORIDE PLAIN (PROMETHAZINE HYDROCHLORIDE)
6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE PLAIN
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N008381
Product Number: 004
Approval Date: Apr 18, 1984
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PROMETHAZINE HYDROCHLORIDE PLAIN (PROMETHAZINE HYDROCHLORIDE)
Proprietary Name: PROMETHAZINE HYDROCHLORIDE PLAIN
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N008381
Product Number: 004
Approval Date: Apr 18, 1984
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE PLAIN
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N008381
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PROMETHAZINE HYDROCHLORIDE PLAIN
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 25MG/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: N008381
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information