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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216725
Company: MANKIND PHARMA

Products on ANDA 216725

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRAMYCIN	TOBRAMYCIN	300MG/4ML	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216725

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-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216725

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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