Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021519
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LUVOX | FLUVOXAMINE MALEATE | 25MG | TABLET;ORAL | Prescription | AB | Yes | No |
LUVOX | FLUVOXAMINE MALEATE | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
LUVOX | FLUVOXAMINE MALEATE | 100MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
12/20/2007 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021519lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021519s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021519_luvox_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021519s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/18/2023 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021519s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021519Orig1s026ltr.pdf | |
09/20/2022 | SUPPL-21 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021519Orig1s021Correctedltr.pdf |
09/20/2021 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021519s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/21519Orig1s018ltr.pdf | |
12/16/2019 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021519s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021519Orig1s012ltr.pdf | |
01/04/2017 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021519s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021519Orig1s009ltr.pdf | |
07/18/2014 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021519Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021519Orig1s008ltr.pdf | |
10/23/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/10/2013 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/28/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/24/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/30/2012 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021519s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021519Orig1s003ltr.pdf | |
03/16/2011 | SUPPL-2 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021519s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021519s002ltr.pdf | |
02/24/2009 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021519s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021519s001,022033s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/18/2023 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021519s026lbl.pdf | |
09/20/2021 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021519s018lbl.pdf | |
12/16/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021519s012lbl.pdf | |
01/04/2017 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021519s009lbl.pdf | |
07/18/2014 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021519Orig1s008lbl.pdf | |
11/30/2012 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021519s003lbl.pdf | |
03/16/2011 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021519s002lbl.pdf | |
02/24/2009 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021519s001lbl.pdf | |
12/20/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021519lbl.pdf |
LUVOX
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 |