Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214478
Company: MANKIND PHARMA

Products on ANDA 214478

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRAMYCIN	TOBRAMYCIN	300MG/5ML	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214478

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214478

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