Product Details for ANDA 077457
OCTREOTIDE ACETATE (PRESERVATIVE FREE) (OCTREOTIDE ACETATE)
EQ 0.05MG BASE/ML
Marketing Status: Prescription
EQ 0.1MG BASE/ML
Marketing Status: Prescription
EQ 0.5MG BASE/ML
Marketing Status: Prescription
EQ 0.05MG BASE/ML
Marketing Status: Prescription
Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.05MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A077457
Product Number: 001
Approval Date: Feb 10, 2006
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
OCTREOTIDE ACETATE (PRESERVATIVE FREE) (OCTREOTIDE ACETATE)
Proprietary Name: OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.05MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A077457
Product Number: 001
Approval Date: Feb 10, 2006
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 0.1MG BASE/ML
Marketing Status: Prescription
Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.1MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A077457
Product Number: 002
Approval Date: Feb 10, 2006
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
OCTREOTIDE ACETATE (PRESERVATIVE FREE) (OCTREOTIDE ACETATE)
Proprietary Name: OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.1MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A077457
Product Number: 002
Approval Date: Feb 10, 2006
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 0.5MG BASE/ML
Marketing Status: Prescription
Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.5MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A077457
Product Number: 003
Approval Date: Feb 10, 2006
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.5MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A077457
Product Number: 003
Approval Date: Feb 10, 2006
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information