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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resubmission Acknowledgment Letter - Isoplate Solution

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

Our STN: NDA BN090067
 
 
B. Braun Medical, Inc.
Attention:  Ms. Rebecca Stolarick
901 Macron Boulevard
Allentown, PA 18109
 
Dear Ms. Stolarick
 
We acknowledge receipt on January 4, 2013, of your January 4, 2013, resubmission to your new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Isoplate Solution, magnesium chloride USP 30mg/100mL.
 
We consider this a complete, class 1 response to our May 8, 2012, action letter. Therefore, the goal date is March 5, 2013.
 
If you have any questions, call Sonday L. Kelly, MS, RAC, Regulatory Project Manager, at (301) 827-6162.
 
Sincerely,
 
 /s/
 
Iliana Valencia, MS
Chief, Regulatory Project Management Branch
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research