Post on 05-Feb-2021
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
205874Orig1s000
CHEMISTRY REVIEW(S)
---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------
MONICA D COOPER07/29/2014For Review of the Drug Substance
THOMAS M WONG07/29/2014Thomas Wong reviewed the drug product portion of the application.
OLEN M STEPHENS07/29/2014
Reference ID: 3600789
---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------
MONICA D COOPER03/31/2014
THOMAS M WONG03/31/2014
OLEN M STEPHENS03/31/2014CMC Recommendation is for a complete response action. A draft list of deficiency comments areattached to the end of the review.
Reference ID: 3480928
7.
Are drug substance manufacturing sites identified on FDA Form 356h or associated continuation sheet? For each site, does the application list: • Name of facility, • Full address of facility including
street, city, state, country • FEI number for facility (if
previously registered with FDA) • Full name and title, telephone, fax
number and email for on-site contact person.
• Is the manufacturing responsibility and function identified for each facility?, and
• DMF number (if applicable)
X
8.
Are drug product manufacturing sites are identified on FDA Form 356h or associated continuation sheet. For each site, does the application list: • Name of facility, • Full address of facility including
street, city, state, country • FEI number for facility (if
previously registered with FDA) • Full name and title, telephone, fax
number and email for on-site contact person.
• Is the manufacturing responsibility and function identified for each facility?, and
• DMF number (if applicable)
X
9.
Are additional manufacturing, packaging and control/testing laboratory sites are identified on FDA Form 356h or associated continuation sheet. For each site, does the application list: • Name of facility, • Full address of facility including
street, city, state, country • FEI number for facility (if
previously registered with FDA) • Full name and title, telephone, fax
number and email for on-site contact person.
• Is the manufacturing responsibility and function identified for each facility?, and
• DMF number (if applicable)
X
Reference ID: 3365503
---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------
KASTURI SRINIVASACHAR08/29/2013
RAMESH K SOOD08/30/2013
Reference ID: 3365503