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FDA Approval

Trazodone Hydrochloride

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
Trazodone(100 mg in 1 1)

Products2

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

Trazodone Hydrochloride

Product Details

NDC Product Code
67046-742
Application Number
ANDA072193
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 1, 2009
magnesium stearateInactive
Code: 70097M6I30Class: IACT
polydextroseInactive
Code: VH2XOU12IEClass: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIBQuantity: 100 mg in 1 1
hypromelloseInactive
Code: 3NXW29V3WOClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT

Trazodone Hydrochloride

Product Details

NDC Product Code
67046-739
Application Number
ANDA072192
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 1, 2009
TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIBQuantity: 50 mg in 1 1
hypromelloseInactive
Code: 3NXW29V3WOClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polydextroseInactive
Code: VH2XOU12IEClass: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
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