Approval for an amendment to the drug master file for the following changes: 1) additional process development work for the purification process; 2) validation of the purification process improvements;3) site transfer for the purification process; 4) change to a specification of a starting material; 5. Additional sizes for the outer container and inner bags for the purification process; and 6) updated stability information.
| Device | BREATHTEK UBT FOR H.PYLORI KIT |
| Classification Name | Test, Urea Adult And Pediatric (breath), |
| Generic Name | Test, Urea Adult And Pediatric (breath), |
| Applicant | OTSUKA AMERICA PHARMACEUTICAL, INC. |
| Date Received | 2015-01-13 |
| Decision Date | 2015-03-05 |
| PMA | P100025 |
| Supplement | S008 |
| 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