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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216725
Company: MANKIND PHARMA
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
09/22/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/30/2023 SUPPL-2 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
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