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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065461
Company: SANDOZ

Products on ANDA 065461

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 065461

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/10/2009	ORIG-1	Approval			Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065461s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065461s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/065461Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2024	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
05/01/2023	SUPPL-37	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
05/01/2023	SUPPL-36	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/01/2023	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
09/17/2019	SUPPL-32	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/25/2019	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
03/25/2019	SUPPL-29	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
11/20/2015	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
02/27/2014	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
05/07/2013	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/10/2012	SUPPL-12	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
10/12/2012	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/27/2012	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/27/2011	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/18/2011	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/27/2011	SUPPL-6	Labeling-Proprietary Name Change		Label is not available on this site.

Labels for ANDA 065461

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/10/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065461s000lbl.pdf

Therapeutic Equivalents for ANDA 065461

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	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	210929	HANGZHOU ZHONGMEI
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	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	210929	HANGZHOU ZHONGMEI
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	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	210929	HANGZHOU ZHONGMEI
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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