Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070346
Company: PAR PHARM

Products on ANDA 070346

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070346

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.

Therapeutic Equivalents for ANDA 070346

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
MIDAMOR	AMILORIDE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	Yes	AB	018200	PADAGIS US