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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203740
Company: ALKEM LABS LTD

Products on ANDA 203740

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 203740

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/12/2020	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
04/19/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/19/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/19/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203740

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

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