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FDA Approval

Terazosin

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

FDA Approval Summary

Effective Date
January 19, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Terazosin(1 mg in 1 1)

Manufacturing Establishments1

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

State of Florida DOH Central Pharmacy

State of Florida DOH Central Pharmacy

829348114

Products1

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

Terazosin

Product Details

NDC Product Code
53808-1056
Application Number
ANDA075317
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 19, 2015
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TerazosinActive
Code: D32S14F082Class: ACTIMQuantity: 1 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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