Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071111
Company: BARR
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 Prescription AB 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
05/10/1988 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
09/18/2002 SUPPL-25 Labeling

Label is not available on this site.

07/15/2002 SUPPL-24 Labeling

Label is not available on this site.

12/21/1999 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

10/16/2000 SUPPL-22 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/16/2000 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/01/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/25/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/14/1993 SUPPL-14 Labeling

Label is not available on this site.

04/03/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/16/1991 SUPPL-10 Labeling

Label is not available on this site.

03/26/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/06/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; EQ 5MG ANHYDROUS;50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET;ORAL Prescription No AB 071111 BARR
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET;ORAL Prescription No AB 073209 MYLAN

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