Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 209621

Expand all

TOBRAMYCIN SULFATE (TOBRAMYCIN SULFATE)
EQ 10MG BASE/ML
Marketing Status: Prescription

Active Ingredient: TOBRAMYCIN SULFATE
Proprietary Name: TOBRAMYCIN SULFATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A209621
Product Number: 001
Approval Date: Feb 11, 2021
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

TOBRAMYCIN SULFATE (TOBRAMYCIN SULFATE)
EQ 40MG BASE/ML
Marketing Status: Prescription

Active Ingredient: TOBRAMYCIN SULFATE
Proprietary Name: TOBRAMYCIN SULFATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 40MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A209621
Product Number: 002
Approval Date: Feb 11, 2021
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information