Product Details for NDA 010926
PHENERGAN (PROMETHAZINE HYDROCHLORIDE)
12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PHENERGAN
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N010926
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
PHENERGAN (PROMETHAZINE HYDROCHLORIDE)
Proprietary Name: PHENERGAN
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N010926
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PHENERGAN
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Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N010926
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PHENERGAN
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Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N010926
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information