Product Details for NDA 215252
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (DILTIAZEM HYDROCHLORIDE)
125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N215252
Product Number: 001
Approval Date: Oct 28, 2021
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N215252
Product Number: 001
Approval Date: Oct 28, 2021
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N215252
Product Number: 002
Approval Date: Oct 28, 2021
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 250MG/250ML (1MG/ML) **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: N215252
Product Number: 002
Approval Date: Oct 28, 2021
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information