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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081190
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 100MG 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
01/24/1992 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-6 Labeling-Package Insert

Label is not available on this site.

12/13/1995 SUPPL-4 Labeling

Label is not available on this site.

09/12/1995 SUPPL-3 Labeling

Label is not available on this site.

08/03/1993 SUPPL-2 Labeling

Label is not available on this site.

10/06/1992 SUPPL-1 Labeling

Label is not available on this site.

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