NDC 0378-0412

Fluvoxamine Maleate

Fluvoxamine Maleate

Fluvoxamine Maleate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Fluvoxamine Maleate.

Product ID0378-0412_25f30071-57a5-4c6b-9a96-cdc1d884cfa9
NDC0378-0412
Product TypeHuman Prescription Drug
Proprietary NameFluvoxamine Maleate
Generic NameFluvoxamine Maleate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2000-12-20
Marketing End Date2020-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA075889
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFLUVOXAMINE MALEATE
Active Ingredient Strength50 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 0378-0412-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0412-01)
Marketing Start Date2000-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0412-05 [00378041205]

Fluvoxamine Maleate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075889
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-12-20
Marketing End Date2014-12-18

NDC 0378-0412-01 [00378041201]

Fluvoxamine Maleate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075889
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-12-20
Marketing End Date2020-05-31

Drug Details

Pharmacological Class

  • Serotonin Reuptake Inhibitor [EPC]
  • Serotonin Uptake Inhibitors [MoA]

NDC Crossover Matching brand name "Fluvoxamine Maleate" or generic name "Fluvoxamine Maleate"

NDCBrand NameGeneric Name
0185-0017fluvoxamine maleatefluvoxamine maleate
0185-0027fluvoxamine maleatefluvoxamine maleate
0185-0157fluvoxamine maleatefluvoxamine maleate
0228-2848Fluvoxamine MaleateFluvoxamine Maleate
0228-2849Fluvoxamine MaleateFluvoxamine Maleate
0378-0407Fluvoxamine Maleatefluvoxamine maleate
0378-0412Fluvoxamine Maleatefluvoxamine maleate
0378-0414Fluvoxamine Maleatefluvoxamine maleate
0615-7569Fluvoxamine MaleateFluvoxamine Maleate
0832-1670Fluvoxamine maleateFluvoxamine maleate
0832-1671Fluvoxamine maleateFluvoxamine maleate
0832-1672Fluvoxamine maleateFluvoxamine maleate
10370-175Fluvoxamine MaleateFluvoxamine Maleate
10370-176Fluvoxamine MaleateFluvoxamine Maleate
13668-290Fluvoxamine MaleateFluvoxamine Maleate
13668-291Fluvoxamine MaleateFluvoxamine Maleate
33261-683fluvoxamine maleateFluvoxamine maleate
49349-991FLuvoxamine MaleateFLUVOXAMINE MALEATE
50090-5988fluvoxamine maleateFluvoxamine maleate
50268-340Fluvoxamine MaleateFluvoxamine Maleate
50268-341Fluvoxamine MaleateFluvoxamine Maleate
50268-342Fluvoxamine MaleateFluvoxamine Maleate
51079-992Fluvoxamine Maleatefluvoxamine maleate
51079-993Fluvoxamine Maleatefluvoxamine maleate
57664-357FLUVOXAMINE MALEATEfluvoxamine maleate
57664-361FLUVOXAMINE MALEATEfluvoxamine maleate
57664-362FLUVOXAMINE MALEATEfluvoxamine maleate
60505-0164Fluvoxamine MaleateFluvoxamine Maleate
68151-0637fluvoxamine maleatefluvoxamine maleate
68788-7219fluvoxamine maleatefluvoxamine maleate
70518-1057fluvoxamine maleatefluvoxamine maleate
70518-1643fluvoxamine maleatefluvoxamine maleate
70518-1789fluvoxamine maleatefluvoxamine maleate
71335-0264fluvoxamine maleatefluvoxamine maleate
60505-0166Fluvoxamine MaleateFluvoxamine Maleate
60505-0165Fluvoxamine MaleateFluvoxamine Maleate
62559-158fluvoxamine maleatefluvoxamine maleate
62559-159fluvoxamine maleatefluvoxamine maleate
62559-160fluvoxamine maleatefluvoxamine maleate
63629-4676fluvoxamine maleatefluvoxamine maleate
63629-8018fluvoxamine maleatefluvoxamine maleate

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.