Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070347
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDRO-RIDE 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
08/06/1986 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
05/13/1996 SUPPL-12 Labeling

Label is not available on this site.

05/13/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/24/1996 SUPPL-10 Labeling

Label is not available on this site.

03/28/1995 SUPPL-9 Labeling

Label is not available on this site.

01/05/1995 SUPPL-8 Labeling

Label is not available on this site.

09/10/1992 SUPPL-7 Labeling

Label is not available on this site.

10/27/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/27/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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