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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
Effective Date
June 30, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Trazodone(300 mg in 1 1)

Products1

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
0555-0711
Application Number
ANDA071196
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2020
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIBQuantity: 300 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
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