Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073334
Company: WATSON LABS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/19/1991 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
04/12/2001 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

09/13/2000 SUPPL-15 Labeling

Label is not available on this site.

03/21/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

07/08/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/22/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/22/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/22/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/27/1993 SUPPL-4 Labeling

Label is not available on this site.

06/23/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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