Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062268
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOXACILLIN SODIUM CLOXACILLIN SODIUM EQ 125MG BASE/5ML FOR SOLUTION;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
09/15/1980 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-20 Manufacturing (CMC)-Facility

Label is not available on this site.

12/22/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/19/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/30/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/22/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/29/1993 SUPPL-15 Labeling

Label is not available on this site.

01/13/1994 SUPPL-14 Labeling

Label is not available on this site.

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