Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084325
Company: LANNETT CO INC

Products on ANDA 084325

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084325

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/24/1976	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-49	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/18/2011	SUPPL-44	Labeling-Package Insert		Label is not available on this site.
03/06/2008	SUPPL-38	Labeling		Label is not available on this site.
08/06/2007	SUPPL-35	Labeling		Label is not available on this site.
03/08/1989	SUPPL-34	Bioequivalence		Label is not available on this site.
11/22/1983	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
11/22/1983	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
11/23/1982	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
11/23/1982	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.