Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 084878
Company: HIKMA INTL PHARMS

Products on ANDA 084878

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084878

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/1977	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
08/20/2020	SUPPL-50	Labeling-Package Insert		Label is not available on this site.
08/17/2011	SUPPL-46	Labeling-Package Insert		Label is not available on this site.
07/12/2006	SUPPL-40	Manufacturing (CMC)-New Strength		Label is not available on this site.
07/12/2006	SUPPL-39	Manufacturing (CMC)-New Strength		Label is not available on this site.
03/24/2004	SUPPL-36	Labeling		Label is not available on this site.
07/28/1992	SUPPL-35	Labeling		Label is not available on this site.
02/07/1991	SUPPL-32	Bioequivalence		Label is not available on this site.
03/28/1991	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
11/27/1992	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
04/25/1989	SUPPL-25	Labeling		Label is not available on this site.
11/29/1988	SUPPL-24	Labeling		Label is not available on this site.
12/20/1985	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
07/20/1983	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/09/1982	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.