Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070346
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/22/1986 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/18/2004 SUPPL-12 Labeling

Label is not available on this site.

09/16/2002 SUPPL-11 Labeling

Label is not available on this site.

06/07/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/24/1989 SUPPL-7 Labeling

Label is not available on this site.

05/19/1989 SUPPL-6 Labeling

Label is not available on this site.

10/05/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/16/1986 SUPPL-1 Manufacturing (CMC)

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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