Product Details for NDA 208418
CALCIUM GLUCONATE (CALCIUM GLUCONATE)
1GM/10ML (100MG/ML)
Marketing Status: Prescription
5GM/50ML (100MG/ML)
Marketing Status: Prescription
10GM/100ML (100MG/ML)
Marketing Status: Prescription
1GM/50ML (20MG/ML)
Marketing Status: Prescription
2GM/100ML (20MG/ML)
Marketing Status: Prescription
1GM/10ML (100MG/ML)
Marketing Status: Prescription
Active Ingredient: CALCIUM GLUCONATE
Proprietary Name: CALCIUM GLUCONATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/10ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N208418
Product Number: 001
Approval Date: Jun 15, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
CALCIUM GLUCONATE (CALCIUM GLUCONATE)
Proprietary Name: CALCIUM GLUCONATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/10ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N208418
Product Number: 001
Approval Date: Jun 15, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
5GM/50ML (100MG/ML)
Marketing Status: Prescription
Active Ingredient: CALCIUM GLUCONATE
Proprietary Name: CALCIUM GLUCONATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5GM/50ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N208418
Product Number: 002
Approval Date: Jun 15, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
CALCIUM GLUCONATE (CALCIUM GLUCONATE)
Proprietary Name: CALCIUM GLUCONATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5GM/50ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N208418
Product Number: 002
Approval Date: Jun 15, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
10GM/100ML (100MG/ML)
Marketing Status: Prescription
Active Ingredient: CALCIUM GLUCONATE
Proprietary Name: CALCIUM GLUCONATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10GM/100ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N208418
Product Number: 003
Approval Date: Jun 15, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
CALCIUM GLUCONATE IN SODIUM CHLORIDE (CALCIUM GLUCONATE)
Proprietary Name: CALCIUM GLUCONATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10GM/100ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N208418
Product Number: 003
Approval Date: Jun 15, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
1GM/50ML (20MG/ML)
Marketing Status: Prescription
Active Ingredient: CALCIUM GLUCONATE
Proprietary Name: CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/50ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N208418
Product Number: 004
Approval Date: Jun 17, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
CALCIUM GLUCONATE IN SODIUM CHLORIDE (CALCIUM GLUCONATE)
Proprietary Name: CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/50ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N208418
Product Number: 004
Approval Date: Jun 17, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
2GM/100ML (20MG/ML)
Marketing Status: Prescription
Active Ingredient: CALCIUM GLUCONATE
Proprietary Name: CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2GM/100ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N208418
Product Number: 005
Approval Date: Jun 17, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: CALCIUM GLUCONATE IN SODIUM CHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2GM/100ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N208418
Product Number: 005
Approval Date: Jun 17, 2021
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information