Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011613
Company: UCB INC
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IONAMIN PHENTERMINE RESIN COMPLEX EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
IONAMIN PHENTERMINE RESIN COMPLEX EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No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
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.

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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