Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205501
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 07/13/2015 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205501Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/10/2023 | SUPPL-13 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2020 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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 |