Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218089
Company: MANKIND PHARMA LTD

Products on ANDA 218089

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REVEFENACIN	REVEFENACIN	175MCG/3ML	SOLUTION;INHALATION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218089

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/06/2025	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218089Orig1s000TAltr.pdf