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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210915
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

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
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