Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204180
Company: WINDLAS HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/07/2015 ORIG-1 Approval

Label is not available on this site.

AMILORIDE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 070346 PAR PHARM
AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 079133 SIGMAPHARM LABS LLC
AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204180 WINDLAS HLTHCARE
MIDAMOR AMILORIDE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 018200 PADDOCK LLC

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