Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062286
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE;ORAL Prescription AB No No
DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE;ORAL Prescription AB 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
06/03/1982 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
09/29/2015 SUPPL-82 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-81 Labeling-Package Insert

Label is not available on this site.

03/17/2009 SUPPL-78 Labeling

Label is not available on this site.

10/21/2004 SUPPL-76 Labeling

Label is not available on this site.

03/14/2002 SUPPL-70 Manufacturing (CMC)-Facility

Label is not available on this site.

02/20/2002 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/2001 SUPPL-67 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-66 Manufacturing (CMC)-Facility

Label is not available on this site.

12/10/1997 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

05/15/1996 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

10/10/1991 SUPPL-62 Labeling

Label is not available on this site.

03/10/1992 SUPPL-61 Labeling

Label is not available on this site.

12/15/1988 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

DICLOXACILLIN SODIUM

CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE;ORAL Prescription No AB 061454 SANDOZ
DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE;ORAL Prescription No AB 062286 TEVA

CAPSULE;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE;ORAL Prescription No AB 061454 SANDOZ
DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE;ORAL Prescription No AB 062286 TEVA

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