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FDA Approval

Paroxetine

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

FDA Approval Summary

Company
Contract Pharmacy Services-PA
DUNS: 945429777
Effective Date
August 11, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Paroxetine(20 mg in 1 1)

Products4

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

Paroxetine

Product Details

NDC Product Code
67046-531
Application Number
ANDA077584
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 31, 2010
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: 3I3T11UD2SClass: ACTIBQuantity: 20 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT

Paroxetine

Product Details

NDC Product Code
67046-532
Application Number
ANDA077584
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 31, 2010
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Code: 3I3T11UD2SClass: ACTIBQuantity: 30 mg in 1 1
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
PEG-150 DISTEARATEInactive
Code: 6F36Q0I0ACClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT

Paroxetine

Product Details

NDC Product Code
67046-530
Application Number
ANDA077584
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 31, 2010
Code: 3I3T11UD2SClass: ACTIBQuantity: 10 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT

Paroxetine

Product Details

NDC Product Code
67046-533
Application Number
ANDA077584
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 31, 2010
Code: 3I3T11UD2SClass: ACTIBQuantity: 40 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
PEG-150 DISTEARATEInactive
Code: 6F36Q0I0ACClass: IACT
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