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FDA Approval

Levomilnacipran

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Amneal Pharmaceuticals LLC

DUNS: 123797875

Effective Date

November 16, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Levomilnacipran(40 mg in 1 1)

Products4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Levomilnacipran

Product Details

NDC Product Code

65162-960

Application Number

ANDA210790

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 13, 2023

Ingredients

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QYClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

LevomilnacipranActive

Code: 371U2ZK31UClass: ACTIMQuantity: 40 mg in 1 1

Levomilnacipran

Product Details

NDC Product Code

65162-437

Application Number

ANDA210790

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 13, 2023

Ingredients

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

LevomilnacipranActive

Code: 371U2ZK31UClass: ACTIMQuantity: 80 mg in 1 1

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QYClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

Levomilnacipran

Product Details

NDC Product Code

65162-411

Application Number

ANDA210790

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 13, 2023

Ingredients

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QYClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

LevomilnacipranActive

Code: 371U2ZK31UClass: ACTIMQuantity: 20 mg in 1 1

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Levomilnacipran

Product Details

NDC Product Code

65162-455

Application Number

ANDA210790

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 13, 2023

Ingredients

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QYClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

LevomilnacipranActive

Code: 371U2ZK31UClass: ACTIMQuantity: 120 mg in 1 1

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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