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FDA Approval

paroxetine hydrochloride

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

FDA Approval Summary

Company

Oxford Pharmaceuticals, LLC

DUNS: 079638266

Effective Date

November 1, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Paroxetine(30 mg in 1 1)

Manufacturing Establishments1

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

Oxford Pharmaceuticals, LLC

Labeler

Oxford Pharmaceuticals, LLC

DUNS Number

079638266

Products4

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

paroxetine hydrochloride

Product Details

NDC Product Code

69584-673

Application Number

ANDA076968

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 1, 2022

Ingredients

ParoxetineActive

Code: X2ELS050D8Class: ACTIMQuantity: 30 mg in 1 1

Dibasic Calcium Phosphate DihydrateInactive

Code: O7TSZ97GEPClass: IACT

Sodium Starch Glycolate Type A PotatoInactive

Code: 5856J3G2A2Class: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

PolydextroseInactive

Code: VH2XOU12IEClass: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

Polyethylene Glycol, UnspecifiedInactive

Code: 3WJQ0SDW1AClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

TriacetinInactive

Code: XHX3C3X673Class: IACT

paroxetine hydrochloride

Product Details

NDC Product Code

69584-671

Application Number

ANDA076968

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 1, 2022

Ingredients

Dibasic Calcium Phosphate DihydrateInactive

Code: O7TSZ97GEPClass: IACT

ParoxetineActive

Code: X2ELS050D8Class: ACTIMQuantity: 10 mg in 1 1

Sodium Starch Glycolate Type A PotatoInactive

Code: 5856J3G2A2Class: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Polyethylene Glycol, UnspecifiedInactive

Code: 3WJQ0SDW1AClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

PolydextroseInactive

Code: VH2XOU12IEClass: IACT

TriacetinInactive

Code: XHX3C3X673Class: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT

paroxetine hydrochloride

Product Details

NDC Product Code

69584-672

Application Number

ANDA076968

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 1, 2022

Ingredients

Polyethylene Glycol, UnspecifiedInactive

Code: 3WJQ0SDW1AClass: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

PolydextroseInactive

Code: VH2XOU12IEClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

TriacetinInactive

Code: XHX3C3X673Class: IACT

D&C Yellow No. 10 Aluminum LakeInactive

Code: CQ3XH3DET6Class: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

ParoxetineActive

Code: X2ELS050D8Class: ACTIMQuantity: 20 mg in 1 1

Dibasic Calcium Phosphate DihydrateInactive

Code: O7TSZ97GEPClass: IACT

Sodium Starch Glycolate Type A PotatoInactive

Code: 5856J3G2A2Class: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

paroxetine hydrochloride

Product Details

NDC Product Code

69584-674

Application Number

ANDA076968

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 1, 2022

Ingredients

Sodium Starch Glycolate Type A PotatoInactive

Code: 5856J3G2A2Class: IACT

ParoxetineActive

Code: X2ELS050D8Class: ACTIMQuantity: 40 mg in 1 1

Fd&C Blue No. 2Inactive

Code: L06K8R7DQKClass: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Indigotindisulfonate SodiumInactive

Code: D3741U8K7LClass: IACT

Dibasic Calcium Phosphate DihydrateInactive

Code: O7TSZ97GEPClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

PolydextroseInactive

Code: VH2XOU12IEClass: IACT

Polyethylene Glycol, UnspecifiedInactive

Code: 3WJQ0SDW1AClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

TriacetinInactive

Code: XHX3C3X673Class: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT

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