Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073357
Company: SANDOZ
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
11/27/1991 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
12/01/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/12/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/15/1993 SUPPL-2 Labeling

Label is not available on this site.

01/24/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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