Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065461
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription AB No No
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription AB No No
TACROLIMUS TACROLIMUS EQ 5MG 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
08/10/2009 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065461s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065461s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/065461Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/25/2019 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

03/25/2019 SUPPL-29 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

11/20/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

02/27/2014 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

05/07/2013 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

12/10/2012 SUPPL-12 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

10/12/2012 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/27/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/27/2011 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/18/2011 SUPPL-8 Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/27/2011 SUPPL-6 Labeling-Proprietary Name Change

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/10/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065461s000lbl.pdf

TACROLIMUS

CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROGRAF TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription Yes AB 050708 ASTELLAS
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 091195 ACCORD HLTHCARE
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 206651 BELCHER PHARMS LLC
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 090509 DR REDDYS LABS LTD
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 090596 MYLAN
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 090802 PANACEA BIOTEC LTD
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 065461 SANDOZ
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 090687 STRIDES PHARMA

CAPSULE;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROGRAF TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription Yes AB 050708 ASTELLAS
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 091195 ACCORD HLTHCARE
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 206651 BELCHER PHARMS LLC
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 090509 DR REDDYS LABS LTD
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 090596 MYLAN
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 090802 PANACEA BIOTEC LTD
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 065461 SANDOZ
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 090687 STRIDES PHARMA

CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROGRAF TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription Yes AB 050708 ASTELLAS
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 091195 ACCORD HLTHCARE
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 206651 BELCHER PHARMS LLC
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 090509 DR REDDYS LABS LTD
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 090596 MYLAN
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 090802 PANACEA BIOTEC LTD
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 065461 SANDOZ
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 090687 STRIDES PHARMA

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