Tobramycin (Page 4 of 4)

HOW SUPPLIED

Tobramycin for Injection, USP Pharmacy Bulk Package, contains tobramycin sulfate equivalent to 1200 mg of tobramycin and supplied as follows:

45932-0027-1 1 bottle per carton
45932-0027-2 6 bottles per carton
Storage
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

REFERENCES

1. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard–8th ed., CLSI document M07-A8. Clinical and Laboratory Standards Institute, Wayne, PA. January, 2009.

2. Performance Standards for Antimicrobial Susceptibility Testing; 21st Informational Supplement. CLSI document M100-S21. Clinical and Laboratory Standards Institute, Wayne, PA. January, 2011.

3. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard–10th ed., CLSI document M02-A10. Clinical and Laboratory Standards Institute, Wayne, PA. January, 2009.

Manufactured for:

Xellia Pharmaceuticals ApS

Dalslandsgade 11

2300 Copenhagen S

Denmark

Made in India August 2014

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tobramycin-label-02
(click image for full-size original)
Tobramycin-carton-01
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Tobramycin-carton-06
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TOBRAMYCIN tobramycin injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45932-0027
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOBRAMYCIN SULFATE (TOBRAMYCIN) TOBRAMYCIN 1200 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
SULFURIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45932-0027-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (45932-0027-1)
2 NDC:45932-0027-2 6 BOTTLE in 1 CARTON contains a BOTTLE
2 30 mL in 1 BOTTLE This package is contained within the CARTON (45932-0027-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205685 04/10/2014
Labeler — Xellia Pharmaceuticals ApS (305814345)
Establishment
Name Address ID/FEI Operations
Gland Pharma Limited 918601238 MANUFACTURE (45932-0027)

Revised: 12/2015 Xellia Pharmaceuticals ApS

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