Product Details for ANDA 075957
OCTREOTIDE ACETATE (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
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: A075957
Product Number: 001
Approval Date: Oct 3, 2005
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
Proprietary Name: OCTREOTIDE ACETATE
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: A075957
Product Number: 001
Approval Date: Oct 3, 2005
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 0.1MG BASE/ML
Marketing Status: Prescription
Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: OCTREOTIDE ACETATE
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: A075957
Product Number: 002
Approval Date: Oct 3, 2005
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
Proprietary Name: OCTREOTIDE ACETATE
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: A075957
Product Number: 002
Approval Date: Oct 3, 2005
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 0.5MG BASE/ML
Marketing Status: Prescription
Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: OCTREOTIDE ACETATE
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: A075957
Product Number: 003
Approval Date: Oct 3, 2005
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: OCTREOTIDE ACETATE
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: A075957
Product Number: 003
Approval Date: Oct 3, 2005
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information