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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215012
Company: CHENGDU

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE, EXTENDED RELEASE;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
01/25/2024 ORIG-1 Approval STANDARD

Label is not available on this site.

TACROLIMUS

CAPSULE, EXTENDED RELEASE;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASTAGRAF XL TACROLIMUS EQ 0.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 204096 ASTELLAS
TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 215012 CHENGDU

CAPSULE, EXTENDED RELEASE;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASTAGRAF XL TACROLIMUS EQ 1MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 204096 ASTELLAS
TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 215012 CHENGDU

CAPSULE, EXTENDED RELEASE;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASTAGRAF XL TACROLIMUS EQ 5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 204096 ASTELLAS
TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 215012 CHENGDU
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