Product Details for NDA 020286
MONOPRIL-HCT (FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE)
10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
20MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Proprietary Name: MONOPRIL-HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020286
Product Number: 002
Approval Date: Nov 30, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
MONOPRIL-HCT (FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE)
Proprietary Name: MONOPRIL-HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020286
Product Number: 002
Approval Date: Nov 30, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Proprietary Name: MONOPRIL-HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020286
Product Number: 001
Approval Date: Nov 30, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: MONOPRIL-HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020286
Product Number: 001
Approval Date: Nov 30, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information