Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201676
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SIROLIMUS SIROLIMUS 0.5MG TABLET; ORAL Prescription None No No
SIROLIMUS SIROLIMUS 1MG TABLET; ORAL None (Tentative Approval) None No No
SIROLIMUS SIROLIMUS 0.5MG TABLET;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
01/08/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/18/2016 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/18/2016 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/18/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

02/18/2016 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/18/2016 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

SIROLIMUS

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RAPAMUNE SIROLIMUS 0.5MG TABLET;ORAL Prescription Yes AB 021110 PF PRISM CV
SIROLIMUS SIROLIMUS 0.5MG TABLET;ORAL Prescription No AB 201676 ZYDUS PHARMS USA INC

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