Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201676
Company: ZYDUS PHARMS

Products on ANDA 201676

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
SIROLIMUS	SIROLIMUS	0.5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201676

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/15/2023	ORIG-2	Approval	Not Applicable			Label is not available on this site.
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
10/27/2023	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/27/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/27/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/27/2023	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/27/2023	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/27/2023	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/27/2023	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/18/2016	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		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-Medication Guide, Labeling-Package Insert		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.

Therapeutic Equivalents for ANDA 201676

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	214753	ALKEM LABS LTD
SIROLIMUS	SIROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	201578	DR REDDYS
SIROLIMUS	SIROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	208691	GLENMARK PHARMS LTD
SIROLIMUS	SIROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	201676	ZYDUS PHARMS

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
SIROLIMUS	SIROLIMUS	2MG	TABLET;ORAL	Prescription	No	AB	208691	GLENMARK PHARMS LTD
SIROLIMUS	SIROLIMUS	2MG	TABLET;ORAL	Prescription	No	AB	201676	ZYDUS PHARMS

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