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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011613
Company: UCB INC

Products on NDA 011613

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IONAMIN	PHENTERMINE RESIN COMPLEX	EQ 30MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
IONAMIN	PHENTERMINE RESIN COMPLEX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011613

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/1959	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2012	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/011613s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/011613Orig1s027ltr.pdf
10/08/2003	SUPPL-26	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11613slr026ltr.pdf
02/17/1998	SUPPL-24	Labeling		Label is not available on this site.
02/27/1998	SUPPL-23	Labeling		Label is not available on this site.
07/08/1993	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
08/03/1987	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
07/10/1987	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/04/1987	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
09/04/1985	SUPPL-17	Labeling		Label is not available on this site.
07/23/1985	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
12/31/1985	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
06/16/1983	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
04/20/1983	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/07/1984	SUPPL-11	Labeling		Label is not available on this site.
09/25/1980	SUPPL-10	Labeling		Label is not available on this site.
05/02/1980	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
10/31/1978	SUPPL-8	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/10/1975	SUPPL-6	Labeling		Label is not available on this site.

Labels for NDA 011613

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2012	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/011613s027lbl.pdf

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