Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070795
Company: TEVA
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
07/15/1987 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
02/16/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/12/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/24/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/24/1993 SUPPL-11 Labeling

Label is not available on this site.

05/04/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/23/1992 SUPPL-9 Labeling

Label is not available on this site.

06/09/1992 SUPPL-8 Labeling

Label is not available on this site.

05/07/1992 SUPPL-7 Labeling

Label is not available on this site.

08/31/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/08/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/04/1988 SUPPL-4 Labeling

Label is not available on this site.

03/04/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/04/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/28/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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