Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208691
Company: GLENMARK PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SIROLIMUS SIROLIMUS 0.5MG TABLET;ORAL Prescription AB No No
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
10/16/2020 ORIG-1 Approval STANDARD

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 214753 ALKEM LABS LTD
SIROLIMUS SIROLIMUS 0.5MG TABLET;ORAL Prescription No AB 208691 GLENMARK PHARMS LTD
SIROLIMUS SIROLIMUS 0.5MG TABLET;ORAL Prescription No AB 201676 ZYDUS PHARMS

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 214753 ALKEM LABS LTD
SIROLIMUS SIROLIMUS 1MG TABLET;ORAL Prescription No AB 201578 DR REDDYS LABS LTD
SIROLIMUS SIROLIMUS 1MG TABLET;ORAL Prescription No AB 208691 GLENMARK PHARMS 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 214753 ALKEM LABS LTD
SIROLIMUS SIROLIMUS 2MG TABLET;ORAL Prescription No AB 201578 DR REDDYS LABS LTD
SIROLIMUS SIROLIMUS 2MG TABLET;ORAL Prescription No AB 208691 GLENMARK PHARMS LTD

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