FDA.reportPublic FDA data

Application 074823

Type
ANDA
Sponsor
APNAR PHARMA LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 1MG BASENoNo
002TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 2MG BASENoYes
003TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 5MG BASENoNo
004TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1337Terazosin HydrochlorideTerazosinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-1338TerazosinTerazosinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-1339TerazosinTerazosinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-2051Terazosin HydrochlorideTerazosin HydrochlorideSandoz IncANDACurrent
0781-2052Terazosin HydrochlorideTerazosin HydrochlorideSandoz IncANDACurrent
0781-2053Terazosin HydrochlorideTerazosin HydrochlorideSandoz IncANDACurrent
0781-2054Terazosin HydrochlorideTerazosin HydrochlorideSandoz IncANDACurrent
0904-6126Terazosin HydrochlorideTerazosin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6127Terazosin HydrochlorideTerazosin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6128Terazosin HydrochlorideTerazosin HydrochlorideMajor PharmaceuticalsANDACurrent
24689-792Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
24689-792Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
24689-792Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
24689-855Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
24689-855Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
24689-855Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
24689-882Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
24689-882Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
24689-882Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
24689-961Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
24689-961Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
24689-961Terazosin HydrochlorideTerazosin HydrochlorideApnar Pharma LPANDACurrent
50090-0659Terazosin HydrochlorideTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-0659Terazosin HydrochlorideTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-0659Terazosin HydrochlorideTerazosin HydrochlorideA-S Medication SolutionsANDACurrent
50436-4247Terazosin HydrochlorideTerazosin HydrochlorideUnit Dose ServicesANDACurrent
70518-0821Terazosin HydrochlorideTerazosin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0821Terazosin HydrochlorideTerazosin HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-2125Terazosin HydrochlorideTerazosin HydrochlorideBryant Ranch PrepackANDACurrent
71610-594Terazosin HydrochlorideTerazosin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-595Terazosin HydrochlorideTerazosin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22375ORIG1998-03-30