An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213112
Company: CONCORD BIOTECH LTD

Products on ANDA 213112

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213112

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2024	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/05/2024	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/05/2024	SUPPL-7	Labeling		Label is not available on this site.
11/05/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/04/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213112

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	206651	AJENAT PHARMS
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	212297	BIOCON PHARMA
TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	213112	CONCORD BIOTECH LTD
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	206651	AJENAT PHARMS
TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE;ORAL	Prescription	No	AB	203740	ALKEM LABS LTD
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	206651	AJENAT PHARMS
TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE;ORAL	Prescription	No	AB	203740	ALKEM LABS LTD
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

Top