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FDA Approval

Fluoxetine

CompanyNostrum Laboratories Inc. (DUNS: 791142354)

Effective Date

August 1, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Fluoxetine(20 mg in 5 mL)

Manufacturing Establishments (1)

Nostrum Laboratories Inc.

Labeler

Nostrum Laboratories Inc.

DUNS Number

791142354

Products (1)

Fluoxetine

NDC Product Code

29033-503

Application Number

ANDA075292

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 1, 2023

Ingredients

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

FluoxetineActive

Code: I9W7N6B1KJClass: ACTIMQuantity: 20 mg in 5 mL

SUCROSEInactive

Code: C151H8M554Class: IACT

BENZOIC ACIDInactive

Code: 8SKN0B0MIMClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Drug Labeling Information

BOXED WARNING SECTION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

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