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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202088
Company: CITIUS PHARMS

Summary Review

Products on NDA 202088

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUPRENZA	PHENTERMINE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No
SUPRENZA	PHENTERMINE HYDROCHLORIDE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No
SUPRENZA	PHENTERMINE HYDROCHLORIDE	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202088

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2012	ORIG-2	Approval	Efficacy	STANDARD		Label is not available on this site.
06/13/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Label (PDF) Letter (PDF) Letter (PDF) Review Review Summary Review (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202088s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202088s000_2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202088s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202088_suprenza_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202088_suprenza_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202088Origs1s000SumR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202088Orig2s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/18/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/11/2013	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202088Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202088Orig1s006ltr.pdf
06/11/2013	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202088s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202088Orig1s005ltr.pdf
12/05/2012	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202088s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088Orig1s004ltr.pdf
03/27/2012	SUPPL-2	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088s002ltr.pdf
10/13/2011	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202088s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202088s001ltr.pdf

Labels for NDA 202088

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2013	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202088Orig1s006lbl.pdf
06/11/2013	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202088s005lbl.pdf
06/11/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202088s005lbl.pdf
12/05/2012	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202088s004lbl.pdf
10/13/2011	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202088s001lbl.pdf
06/13/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202088s000_2lbl.pdf
06/13/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202088s000lbl.pdf

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