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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091589
Company: TEVA PHARMS USA

Products on ANDA 091589

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 091589

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2013	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091589Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091589Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/2024	SUPPL-12	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
02/06/2020	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/06/2020	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/12/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/12/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/01/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 091589

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091589Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 091589

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

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