Drugs@FDA: FDA-Approved Drugs
Company: UPSHER SMITH LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 100MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/29/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75888ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/31/2023 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
03/30/2023 | SUPPL-41 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
03/30/2023 | SUPPL-40 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
07/29/2015 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
07/29/2015 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
01/09/2013 | SUPPL-26 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
06/11/2009 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
09/14/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
06/27/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
07/24/2006 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
05/03/2005 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
04/20/2005 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
09/30/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
06/10/2004 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
01/22/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
03/15/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
FLUVOXAMINE MALEATE
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 25MG | TABLET;ORAL | Prescription | No | AB | 075902 | APOTEX |
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 25MG | TABLET;ORAL | Prescription | No | AB | 217917 | BIONPHARMA |
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 25MG | TABLET;ORAL | Prescription | No | AB | 075888 | UPSHER SMITH LABS |
LUVOX | FLUVOXAMINE MALEATE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 021519 | ANI PHARMS |
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 50MG | TABLET;ORAL | Prescription | No | AB | 075902 | APOTEX |
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 50MG | TABLET;ORAL | Prescription | No | AB | 217917 | BIONPHARMA |
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 50MG | TABLET;ORAL | Prescription | No | AB | 075888 | UPSHER SMITH LABS |
LUVOX | FLUVOXAMINE MALEATE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 021519 | ANI PHARMS |
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 100MG | TABLET;ORAL | Prescription | No | AB | 075902 | APOTEX |
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 100MG | TABLET;ORAL | Prescription | No | AB | 217917 | BIONPHARMA |
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 100MG | TABLET;ORAL | Prescription | No | AB | 075888 | UPSHER SMITH LABS |
LUVOX | FLUVOXAMINE MALEATE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 021519 | ANI PHARMS |