Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070795
Company: TEVA

Products on ANDA 070795

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	EQ 5MG ANHYDROUS;50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070795

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/1987	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
02/16/1995	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
09/06/1994	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/17/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/12/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
05/24/1993	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/24/1993	SUPPL-11	Labeling		Label is not available on this site.
05/04/1993	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/23/1992	SUPPL-9	Labeling		Label is not available on this site.
06/09/1992	SUPPL-8	Labeling		Label is not available on this site.
05/07/1992	SUPPL-7	Labeling		Label is not available on this site.
08/31/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/08/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/04/1988	SUPPL-4	Labeling		Label is not available on this site.
03/04/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/04/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/28/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.