Drugs@FDA: FDA-Approved Drugs
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| PHENTERMINE RESIN COMPLEX | EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |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| PHENTERMINE RESIN COMPLEX | EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
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. |
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06/16/1983 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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. |
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05/02/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/31/1978 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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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 |