Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091195
Company: ACCORD HLTHCARE
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
08/31/2011 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
10/22/2019 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

10/22/2019 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/28/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/28/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/10/2012 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/28/2012 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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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