Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084324
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Discontinued None No No
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
08/18/2011 SUPPL-65 Labeling-Package Insert

Label is not available on this site.

03/06/2008 SUPPL-59 Labeling

Label is not available on this site.

08/06/2007 SUPPL-56 Labeling

Label is not available on this site.

06/15/1989 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

04/10/1989 SUPPL-54 Bioequivalence

Label is not available on this site.

11/22/1983 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

11/22/1983 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

11/23/1982 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

11/23/1982 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

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