Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018200
Company: PADAGIS US

Products on NDA 18200

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIDAMOR	AMILORIDE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	Yes	No

Labels for NDA 018200

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2002	SUPPL-24	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200S024_Midamor_Prntlbl.pdf