Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091589
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOBRAMYCIN | 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 |
---|---|---|---|---|---|---|---|
10/10/2013 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091589Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091589Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/29/2024 | SUPPL-12 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
02/06/2020 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
02/06/2020 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
10/12/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
10/12/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
09/01/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/10/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091589Orig1s000lbl.pdf |
TOBRAMYCIN
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 |