Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091195
Company: ACCORD HLTHCARE

Products on ANDA 091195

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	BX	No	No
TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE;ORAL	Prescription	BX	No	No
TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE;ORAL	Prescription	BX	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091195

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2011	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
10/22/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/22/2019	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/28/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/28/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/10/2012	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/28/2012	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091195

TACROLIMUS

There are no Therapeutic Equivalents.