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FDA Approval

Prazosin Hydrochloride

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

FDA Approval Summary

Company
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Effective Date
March 20, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Prazosin(1 mg in 1 1)

Manufacturing Establishments1

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

Aphena Pharma Solutions - Tennessee, LLC

Aphena Pharma Solutions - Tennessee, LLC

128385585

Products2

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

Prazosin Hydrochloride

Product Details

NDC Product Code
71610-693
Application Number
ANDA214608
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 20, 2023
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PrazosinActive
Code: X0Z7454B90Class: ACTIMQuantity: 1 mg in 1 1

Prazosin Hydrochloride

Product Details

NDC Product Code
71610-694
Application Number
ANDA214608
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 20, 2023
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PrazosinActive
Code: X0Z7454B90Class: ACTIMQuantity: 2 mg in 1 1
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