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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090802
Company: PANACEA
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
09/28/2012 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
11/18/2019 SUPPL-7 Labeling-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 203740 ALKEM LABS LTD
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 206651 BELCHER
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 212297 BIOCON PHARMA
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 206662 GLENMARK PHARMS 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
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 203740 ALKEM LABS LTD
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 206651 BELCHER
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 212297 BIOCON PHARMA
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE;ORAL Prescription No AB 213112 CONCORD BIOTECH LTD
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 206662 GLENMARK PHARMS 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
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 203740 ALKEM LABS LTD
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 206651 BELCHER
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 212297 BIOCON PHARMA
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE;ORAL Prescription No AB 213112 CONCORD BIOTECH LTD
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 206662 GLENMARK PHARMS 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
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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