Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201578
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SIROLIMUS SIROLIMUS 1MG TABLET;ORAL Prescription AB No No
SIROLIMUS SIROLIMUS 2MG 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
10/27/2014 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
01/14/2016 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/14/2016 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

SIROLIMUS

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RAPAMUNE SIROLIMUS 1MG TABLET;ORAL Prescription Yes AB 021110 PF PRISM CV
SIROLIMUS SIROLIMUS 1MG TABLET;ORAL Prescription No AB 201578 DR REDDYS LABS LTD

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RAPAMUNE SIROLIMUS 2MG TABLET;ORAL Prescription Yes AB 021110 PF PRISM CV
SIROLIMUS SIROLIMUS 2MG TABLET;ORAL Prescription No AB 201578 DR REDDYS LABS LTD

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