Approval for cambridge isotope laboratories, inc. (cil's) amended drug master file (dmf) #11378 on behalf of oapi's pma application which uses the drug as a component of the breathtek ubt for h. Pylori kit. This supplement requests the review of the following changes to the drug master file:1. Process change to manufacturing scale to add 18kg process;2. Update to specifications and test methods for 13c-urea;3. Changes in qc testing locations; and 4. Changes in manufacturing locations for 18kg process.
| Device | BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA) |
| Classification Name | Test, Urea Adult And Pediatric (breath), |
| Generic Name | Test, Urea Adult And Pediatric (breath), |
| Applicant | OTSUKA AMERICA PHARMACEUTICAL, INC. |
| Date Received | 2014-08-08 |
| Decision Date | 2015-02-03 |
| PMA | P100025 |
| Supplement | S007 |
| Product Code | OZA |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | OTSUKA AMERICA PHARMACEUTICAL, INC. 2440 Research Blvd. rockville, MD 20850 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100025 | | Original Filing |
| S014 |
2019-08-12 |
Normal 180 Day Track No User Fee |
| S013 |
2018-04-20 |
30-day Notice |
| S012 |
2017-01-09 |
Real-time Process |
| S011 |
2016-12-06 |
30-day Notice |
| S010 |
2015-09-15 |
Normal 180 Day Track |
| S009 |
2015-07-16 |
Normal 180 Day Track |
| S008 |
2015-01-13 |
Normal 180 Day Track |
| S007 |
2014-08-08 |
Normal 180 Day Track |
| S006 |
2014-01-22 |
Special (immediate Track) |
| S005 |
2013-06-28 |
Normal 180 Day Track |
| S004 |
2013-02-01 |
Normal 180 Day Track |
| S003 |
2012-10-12 |
Special (immediate Track) |
| S002 |
2012-08-31 |
Normal 180 Day Track No User Fee |
| S001 |
2012-03-19 |
Normal 180 Day Track |
NIH GUDID Devices