Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061454
Company: SANDOZ
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 125MG BASE CAPSULE;ORAL Prescription None No No
DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/01/1971 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
01/26/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/26/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/26/2016 SUPPL-7 Labeling

Label is not available on this site.

06/18/2004 SUPPL-5 Labeling

Label is not available on this site.

07/14/2005 SUPPL-1 Labeling

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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