Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088595
Company: DURAMED PHARMS BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE;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
02/29/1984 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
12/04/1989 SUPPL-15 Labeling

Label is not available on this site.

04/14/1989 SUPPL-14 Labeling

Label is not available on this site.

09/02/1988 SUPPL-12 Labeling

Label is not available on this site.

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