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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062222
Company: ANI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXACILLIN SODIUM OXACILLIN SODIUM EQ 250MG BASE CAPSULE;ORAL Discontinued None No No
OXACILLIN SODIUM OXACILLIN SODIUM EQ 500MG BASE 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
03/10/1980 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
07/07/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

12/10/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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