Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205433
Company: PULMOFLOW INC
Company: PULMOFLOW INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KITABIS PAK | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | AN | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/02/2014 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205433s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205433Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/10/2023 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205433s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205433Orig1s008ltr.pdf | |
02/10/2023 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205433s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205433Orig1s007ltr.pdf | |
12/06/2019 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205433s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205433Orig1s005ltr.pdf | |
11/18/2016 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/10/2023 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205433s008lbl.pdf | |
02/10/2023 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205433s007lbl.pdf | |
12/06/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205433s005lbl.pdf | |
12/02/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205433s000lbl.pdf |
KITABIS PAK
SOLUTION;INHALATION; 300MG/5ML
TE Code = AN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KITABIS PAK | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | No | AN | 205433 | PULMOFLOW INC |
TOBI | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | Yes | AN | 050753 | MYLAN SPECIALITY LP |
TOBRAMYCIN | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | No | AN | 212848 | ALKEM LABS LTD |
TOBRAMYCIN | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | No | AN | 205501 | AMNEAL PHARMS |
TOBRAMYCIN | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | No | AN | 207080 | DR REDDYS LABS SA |
TOBRAMYCIN | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | No | AN | 201422 | HIKMA |
TOBRAMYCIN | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | No | AN | 208964 | LUPIN |
TOBRAMYCIN | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | No | AN | 214478 | MANKIND PHARMA |
TOBRAMYCIN | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | No | AN | 217344 | MICRO LABS |
TOBRAMYCIN | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | No | AN | 207136 | SUN PHARM |
TOBRAMYCIN | TOBRAMYCIN | 300MG/5ML | SOLUTION;INHALATION | Prescription | No | AN | 091589 | TEVA PHARMS USA |