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FDA Approval

Fluvoxamine maleate

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

FDA Approval Summary

Company

Upsher-Smith Laboratories, LLC

DUNS: 047251004

Effective Date

September 11, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Fluvoxamine(25 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Upsher-Smith Laboratories, LLC

Labeler

Upsher-Smith Laboratories, LLC

DUNS Number

079111820

Products3

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

Fluvoxamine maleate

Product Details

NDC Product Code

0832-1670

Application Number

ANDA075888

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 31, 2023

Ingredients

FluvoxamineActive

Code: 5LGN83G74VClass: ACTIBQuantity: 25 mg in 1 1

carnauba waxInactive

Code: R12CBM0EIZClass: IACT

METHYLCELLULOSE (15 MPA.S)Inactive

Code: NPU9M2E6L8Class: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

polyethylene glycol, unspecifiedInactive

Code: 3WJQ0SDW1AClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

mannitolInactive

Code: 3OWL53L36AClass: IACT

hypromellose, unspecifiedInactive

Code: 3NXW29V3WOClass: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

ferric oxide yellowInactive

Code: EX438O2MRTClass: IACT

Fluvoxamine maleate

Product Details

NDC Product Code

0832-1671

Application Number

ANDA075888

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 31, 2023

Ingredients

FluvoxamineActive

Code: 5LGN83G74VClass: ACTIBQuantity: 50 mg in 1 1

magnesium stearateInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

carnauba waxInactive

Code: R12CBM0EIZClass: IACT

mannitolInactive

Code: 3OWL53L36AClass: IACT

hypromellose, unspecifiedInactive

Code: 3NXW29V3WOClass: IACT

METHYLCELLULOSE (15 MPA.S)Inactive

Code: NPU9M2E6L8Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

polyethylene glycol, unspecifiedInactive

Code: 3WJQ0SDW1AClass: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACT

ferric oxide yellowInactive

Code: EX438O2MRTClass: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

Fluvoxamine maleate

Product Details

NDC Product Code

0832-1672

Application Number

ANDA075888

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 31, 2023

Ingredients

magnesium stearateInactive

Code: 70097M6I30Class: IACT

FluvoxamineActive

Code: 5LGN83G74VClass: ACTIBQuantity: 100 mg in 1 1

mannitolInactive

Code: 3OWL53L36AClass: IACT

METHYLCELLULOSE (15 MPA.S)Inactive

Code: NPU9M2E6L8Class: IACT

carnauba waxInactive

Code: R12CBM0EIZClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

polyethylene glycol, unspecifiedInactive

Code: 3WJQ0SDW1AClass: IACT

ferric oxide yellowInactive

Code: EX438O2MRTClass: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

hypromellose, unspecifiedInactive

Code: 3NXW29V3WOClass: IACT

ferric oxide redInactive

Code: 1K09F3G675Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACT

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