Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083862
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINIDINE SULFATE QUINIDINE SULFATE 200MG 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
09/02/1976 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
01/07/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/18/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/20/1984 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/20/1984 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/01/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/08/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/08/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/09/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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