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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022206
Company: ABBVIE

Summary Review

Products on NDA 022206

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RAPAFLO	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes
RAPAFLO	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022206

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/08/2008	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022206lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022206s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022206s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022206s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022206s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022206Orig1s016ltr.pdf
11/08/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/12/2013	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022206s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022206Orig1s012ltr.pdf
06/24/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/21/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/14/2012	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022206s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022206Orig1s008ltr.pdf
03/04/2010	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022206s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022206s006ltr.pdf
02/13/2009	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022206s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022206s001ltr.pdf

Labels for NDA 022206

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022206s016lbl.pdf
07/12/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022206s012lbl.pdf
12/14/2012	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022206s008lbl.pdf
03/04/2010	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022206s006lbl.pdf
02/13/2009	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022206s001lbl.pdf
02/13/2009	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022206s001lbl.pdf
10/08/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022206lbl.pdf

Therapeutic Equivalents for NDA 022206

RAPAFLO

CAPSULE;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RAPAFLO	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	Yes	AB	022206	ABBVIE
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	211060	AJANTA PHARMA LTD
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	209745	AMNEAL PHARMS CO
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	210626	AUROBINDO PHARMA LTD
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	204726	CHARTWELL RX
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	213230	CREEKWOOD PHARMS
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	204793	HETERO LABS LTD V
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	206541	LUPIN LTD
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	211166	MACLEODS PHARMS LTD
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	210687	MSN
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	209029	PRINSTON INC

CAPSULE;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RAPAFLO	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	Yes	AB	022206	ABBVIE
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	211060	AJANTA PHARMA LTD
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	209745	AMNEAL PHARMS CO
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	210626	AUROBINDO PHARMA LTD
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	204726	CHARTWELL RX
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	213230	CREEKWOOD PHARMS
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	204793	HETERO LABS LTD V
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	206541	LUPIN LTD
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	211166	MACLEODS PHARMS LTD
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	210687	MSN
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	209029	PRINSTON INC

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