Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210915
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/4ML | 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 |
---|---|---|---|---|---|---|---|
06/26/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210915Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/21/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
TOBRAMYCIN
SOLUTION;INHALATION; 300MG/4ML
TE Code = AN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BETHKIS | TOBRAMYCIN | 300MG/4ML | SOLUTION;INHALATION | Prescription | Yes | AN | 201820 | CHIESI |
TOBRAMYCIN | TOBRAMYCIN | 300MG/4ML | SOLUTION;INHALATION | Prescription | No | AN | 216725 | MANKIND PHARMA |
TOBRAMYCIN | TOBRAMYCIN | 300MG/4ML | SOLUTION;INHALATION | Prescription | No | AN | 210915 | TEVA PHARMS USA |